Ambar, Ambar APS, Ambar Universal APS
Device Facts
| Record ID | K183424 |
|---|---|
| Device Name | Ambar, Ambar APS, Ambar Universal APS |
| Applicant | Dentscare Ltda |
| Product Code | KLE · Dental |
| Decision Date | Dec 13, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3200 |
| Device Class | Class 2 |
Indications for Use
- All classes of direct restoration with composites (class I, II, III, IV and V); - Adhesive luting (in addition to resin cement) of prosthetic pieces (post/cores, crowns, onlays/inlays, veneers etc.) made of fiberglass, ceromer, ceramic, resin and metal; - Adhesive repairs in ceramic and composites. *Only for Ambar Universal APS: Use as metallic or ceramic primer.
Device Story
Ambar APS and Ambar Universal APS are light-curing dental adhesive systems used to bond restorative materials to tooth structure (enamel and dentin). Ambar APS is a 5th generation two-step adhesive; Ambar Universal APS is a 7th generation single-flask system supporting self-etch, selective-etch, and total-etch techniques. Used in dental clinics by professionals for direct restorations, luting of indirect prosthetics, and repairs. The adhesive is applied to the tooth surface and light-cured to facilitate chemical bonding between the tooth and restorative material. Benefits include improved retention and sealing of restorations. The device is supplied in vials.
Clinical Evidence
Bench testing only. Comparative studies against predicate and reference devices evaluated adhesive strength (MPa), degree of conversion, shear bond strength (ISO 29022), pH, viscosity, water sorption, and water solubility. Results demonstrated subject devices have adhesive strength (38.61/38.02 MPa) and conversion rates (53.8/55.8%) equal to or greater than predicates. Stability studies confirmed 2-3 year shelf life.
Technological Characteristics
Light-curing dental adhesives. Composition: MDP, methacrylate monomers, photoinitiators, co-initiators, stabilizers, silica filler, ethanol; Ambar Universal APS includes water and surfactant. Sensing/actuation: chemical bonding via light-activated polymerization. Form factor: liquid in vials. Standards: ISO 29022, ISO 10993 (1, 3, 5, 10, 11).
Indications for Use
Indicated for patients requiring direct composite restorations (all classes), adhesive luting of prosthetic pieces (fiberglass, ceromer, ceramic, resin, metal), and adhesive repairs of ceramic/composites. Ambar Universal APS is also indicated as a metallic or ceramic primer. No specific patient population restrictions.
Regulatory Classification
Identification
A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.
Predicate Devices
- 3M Dent System (Single Bond 2) (K962785)
Reference Devices
- Adhesive EXL 759 (Single Bond Universal) (K110302)
- Adhese Universal (Tetric – N – Bond Universal) (K133318)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2019
DentsCare LTDA % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 12343 NW 25th St Coral Springs, Florida 33065
Re: K183424
Trade/Device Name: Ambar, Ambar APS, Ambar Universal APS Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: November 11, 2019 Received: November 13, 2019
Dear Rodrigo Abreu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K183424
Device Name Ambar APS and Ambar Universal APS
Indications for Use (Describe)
- All classes of direct restoration with composites (class I, II, III, IV and V);
- Adhesive luting (in addition to resin cement) of prosthetic pieces (post/cores, crowns, onlays/inlays, veneers etc.) made of fiberglass, ceromer, ceramic, resin and metal;
- Adhesive repairs in ceramic and composites.
*Only for Ambar Universal APS: Use as metallic or ceramic primer.
Type of Use (Select one or both, as applicable)
| <div> <span> <span></span>Prescription Use (Part 21 CER 801 Subpart D) </span> </div> |
|-------------------------------------------------------------------------------------------|
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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Image /page/3/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with horizontal lines inside. The text includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).
#### Section 5 510(k) SUMMARY
#### Revision date: December 12, 2019
- A) Submitter's Name: DENTSCARE LTDA
Owner / Operator Registration Number: 3007210751
## Manufacture Registration Number: 3007210751
- B) Address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL
- C) Phone and Fax Numbers
Phone: +55 (47) 34416131
- D) Contact Person:
Roberta Uyara
Tel.: +55 (47) 34416131
- E) Preparation Date: December 12, 2019
- F) Classification Name: Resin tooth bonding agent
Common / Usual Name: Tooth Bonding Adhesive
Proprietary Name: Ambar APS and Ambar Universal APS
Product Code: KLE
Class: Class II
Regulation: 21 CFR 872.3200
#### G) Device Description
#### Ambar APS
Ambar APS is a light-curing 5th generation adhesive (two-step adhesive, total etch technique) for bonding restorative materials to dental tissue (enamel and/ or dentin). As the primer and the bonding agent are combined in a single bottle, acid etching is the only previous step needed before applying the adhesive to dentin and enamel.
#### Ambar Universal APS
Ambar Universal APS is a single flask self-etch light-curing adhesive system (Seventh Generation) responsible for the union between tooth structure (enamel and dentin) and restorative materials. The primer and bonding agent are combined in a single flask. Prior use of acid etchant is optional on both tooth 's enamel and dentin, it can be used, therefore, in three ways: self-etch, selective-etch and total-etch.
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Image /page/4/Picture/0 description: The image shows the logo and contact information for Dentscare Ltda. The logo features a stylized letter D with horizontal lines inside. The contact information includes the company's address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and phone number: Ph: 55 - 47 - 3441-6131.
## H) Substantial Equivalence:
The Ambar APS and Ambar Universal APS are equivalent with the following products:
| 510(k) Number | Model | Company |
|--------------------------------|--------------------------------|------------|
| K962785<br>(primary predicate) | 3M Dent System (Single Bond 2) | 3M COMPANY |
## I) Reference Devices:
| 510(k) Number | Model | Company | Indication for Use Comparison | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|------------------------------------------------|------------------------------------------------------|
| K110302 | Adhesive EXL 759 (Single Bond Universal) | 3M COMPANY | Ambar APS and<br>Ambar Universal<br>APS | 3M Dent System<br>(Single Bond 2) | Adhesive EXL 759<br>(Single Bond<br>Universal) | Adhese Universal<br>(Tetric - N – Bond<br>Universal) |
| K133318 | Adhese Universal (Tetric – N – Bond<br>Universal) | Ivoclar | Dentscare | 3M<br>(primary predicate) | 3M | Ivoclar |
| - All classes of<br>direct restoration<br>with composites<br>(class I, II, III, IV<br>and V); | Direct light-cured<br>composite/compomer<br>restorations | All classes of fillings<br>(according to Black)<br>with light-curing<br>composite or<br>compomer filling<br>materials | Direct-placed light-<br>curing composite and<br>compomer restorations | | | |
| - Adhesive luting<br>(in addition to resin<br>cement) of<br>prosthetic pieces<br>(post/cores,<br>crowns,<br>onlays/inlays,<br>veneers etc.) made<br>of fiberglass,<br>ceromer, ceramic,<br>resin and metal;<br>- Adhesive repairs<br>in ceramic and<br>composites.<br>*Only for Ambar<br>Universal APS: Use<br>as metallic or<br>ceramic primer. | Porcelain veneers<br>(when used with<br>RelyX™ Veneer<br>Cement)<br>Crown & bridge,<br>inlay/onlay, bonding<br>amalgam (when used<br>with RelyX™ ARC<br>Adhesive Resin<br>Cement) | Cementation of indirect<br>restorations (inlays,<br>onlays, crowns,<br>bridges, veneers) of<br>composite, compomer,<br>ceramic, and metal<br>when combined with<br>Suglue-10 Adhesive<br>Resin Cement,<br>manufactured by 3M ESPE<br>Cementation of veneers<br>when combined with<br>RelyX Veneer Cement,<br>manufactured by 3M ESPE<br>Bonding of core build-ups<br>made of light-curing<br>composite or core build-up<br>materials<br>Bonding of dual-cure<br>cements and core build-up<br>materials and self-cure<br>composites when combined<br>with Activator EXL 760 | Direct-placed core<br>build-ups with light-, self- and dual-curing composites<br>Adhesive cementation of indirect restorations with light- and dual- curing luting composites | | | |
| | Porcelain / composite<br>repair | Repair of composite or<br>compomer fillings<br>Intraoral repair of<br>composite restorations,<br>porcelain fused to<br>metal, and all-ceramic<br>restorations without<br>extra primer | Repair of fractured<br>composite and<br>compomer restorations. | | | |
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Image /page/5/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with horizontal lines inside. The text includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).
## J) Indications for Use:
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Image /page/6/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color. Inside the "D" are three horizontal lines that resemble sound waves. Below the "D" is the text "DentsCare" in a sans-serif font, also in gray.
. EDGAR NELSON MEISTER, 474, JOINVILLE, ARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
| Not indicated | Surface treatment of<br>porcelain, ceramics<br>(including glass<br>ceramics, zirconia and<br>alumina), metal and<br>composite | Not indicated |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Root surface<br>desensitization | Root surface<br>desensitization | Desensitization of<br>hypersensitive cervical<br>areas |
| Not indicated | Sealing of cavities prior<br>to cementation of<br>amalgamate<br>restorations<br>Sealing of cavities and<br>preparation of tooth<br>stumps prior to<br>temporary cementation<br>of indirect restorations | Sealing of prepared<br>tooth surfaces before<br>temporary / permanent<br>cementation of indirect<br>restorations |
| Not indicated | Bonding of fissure<br>sealants<br>Protective varnish for<br>glass ionomer fillings | Not indicated |
Discussion: The subject devices are adhesive systems that offer the dental professional a wide range of applications. The Ambar APS and Ambar Universal APS are substantially equivalent to the predicate device (Single Bond 2) and the reference devices (Single Bond Universal and Tetric – N – Bond Universal) above in that all are intended to be used as a 21 CFR 872.3200 resin tooth bonding agent. The subject devices are substantially equivalent to Single Bond 2 in terms of indications. Regarding the claim "Use as metallic or ceramic primer", the Ambar Universal APS it similar to the reference predicate, Single Bond Universal, that indicates the use for "Surface treatment of porcelain, ceramics (including glass ceramics, zirconia and alumina), metal and composite."
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Image /page/7/Picture/0 description: The image shows the logo and contact information for Dentscare LTDA. The logo features a stylized letter D with three horizontal lines inside. The text includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).
## K) Technological Characteristics Comparison:
The predicate device used to establish substantial equivalence for the Ambar APS and Ambar Universal APS device is outlined below. This submission will provide a comparison of design, materials, and technical specifications of the Ambar APS and Ambar Universal APS to each of the predicate devices stratified by functional modality.
| Device<br>Manufacturer<br>and Common<br>Name | Ambar APS<br>and Ambar<br>Universal APS<br>Dentscare | 3M Dent<br>System (Single<br>Bond 2)<br>3M<br>(primary predicate) | Adhesive EXL<br>759 (Single<br>Bond<br>Universal)<br>3M | Adhese<br>Universal<br>(Tetric - N -<br>Bond<br>Universal)<br>3M |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| 510k # | K183424 | K962785 | K110302 | K133318 |
| Classification | Class II | Class II | Class II | Class II |
| Regulation # | 21 CFR<br>872.3200 | 21 CFR 872.3200 | 21 CFR<br>872.3200 | 21 CFR<br>872.3200 |
| Product Code | KLE | KLE | KLE | KLE, LBH |
| Classification<br>Name | Resin tooth<br>bonding agent | Resin tooth<br>bonding agent | Resin tooth<br>bonding agent | Resin tooth<br>bonding agent |
| Patient<br>Population | No restriction,<br>it can be<br>applied to<br>general<br>population | No restriction, it<br>can be applied to<br>general<br>population | No restriction,<br>it can be<br>applied to<br>general<br>population | No restriction,<br>it can be<br>applied to<br>general<br>population |
| Prescription<br>Use | RX only | RX only | RX only | RX only |
| Environment | Dental<br>prosthetics and<br>authorized<br>laboratories<br>and clinics.<br>Must be stored<br>in<br>temperatures<br>from 5° to<br>30°C / 41° to<br>86°F. | Dental<br>prosthetics and<br>authorized<br>laboratories and<br>clinics.<br>It can be stored<br>at room<br>temperature. | Dental<br>prosthetics and<br>authorized<br>laboratories<br>and clinics.<br>It can be<br>stored at room<br>temperature. | Dental<br>prosthetics<br>and<br>authorized<br>laboratories<br>and clinics.<br>Store<br>conditions not<br>found. |
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Image /page/8/Picture/4 description: The image shows the logo for DentsCare LTDA. The logo consists of a stylized letter D with three horizontal lines inside it, followed by the text "DentsCare". To the right of the logo is the text "DENTSCARE LTDA AV. EDGAR NELSON SANTA CATARINA 8 Ph: 55 - 47 - 3441-".
AV. EDGAR NELSON MEISTER, 474, JOINVILLE,
SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
| Applicable<br>Standards | ISO 29022; ISO<br>10993. | ISO 29022; ISO<br>10993. | ISO 29022; ISO<br>10993. | ISO 29022; ISO<br>10993. |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Composition | MDP,<br>methacrylate<br>monomers,<br>photo initiators,<br>co-initiators,<br>stabilizers,<br>Inert Load<br>(Silica<br>particles) and<br>Vehicle<br>(ethanol).<br>*Only in Ambar<br>Universal APS:<br>water and<br>surfactant. | Dimethacrylatere<br>sins, HEMA,<br>ethanol, water,<br>photoinitiator<br>system and filler. | MDP,<br>Dimethacrylate<br>resins, HEMA,<br>ethanol, water,<br>photoinitiator<br>system, filler<br>and silane. | Methacrylates,<br>Water,<br>Ethanol,<br>Highly<br>dispersed<br>silicon dioxide,<br>Initiators and<br>Stabilisers. |
| Device<br>Sterilization | Not Applicable | Not Applicable | Not Applicable | Not Applicable |
| Indication of<br>Use | - All classes of<br>direct<br>restoration with<br>composites<br>(class I, II, III,<br>IV and V);<br>- Adhesive<br>luting (in<br>addition to<br>resin cement)<br>of prosthetic<br>pieces<br>(post/cores,<br>crowns,<br>onlays/inlays,<br>veneers etc.)<br>made of<br>fiberglass,<br>ceromer,<br>ceramic, resin<br>and metal; | 3M™ ESPE™<br>Adper™ Single<br>Bond 2 Adhesive<br>is indicated for<br>use in the<br>following types<br>of restorations.<br>- Direct light-<br>cured<br>composite/comp<br>omer<br>restorations<br>- Root surface<br>desensitization<br>-Porcelain /<br>composite repair<br>- Porcelain<br>veneers (when<br>used with<br>RelyX™ Veneer | - All classes of<br>fillings<br>(according to<br>Black) with<br>light-curing<br>composite or<br>compomer<br>filling materials<br>- Cementation<br>of indirect<br>restorations<br>(inlays, onlays,<br>crowns,<br>bridges,<br>veneers) of<br>composite,<br>compomer,<br>ceramic, and<br>metal when<br>combined with<br>Suglue-10<br>Adhesive Resin<br>Cement, | - Direct-<br>placed light-<br>curing<br>composite and<br>compomer<br>restorations.<br>- Direct-<br>placed core<br>build-ups with<br>light-, self-<br>and dual-<br>curing<br>composites.<br>- Repair of<br>fractured<br>composite and<br>compomer<br>restorations.<br>- Adhesive<br>cementation<br>of indirect<br>restorations |
| ceramic and<br>composites. | - Crown &<br>bridge,<br>inlay/onlay,<br>bonding<br>amalgam (when<br>used with<br>RelyX™ ARC<br>Adhesive Resin<br>Cement) | - Cementation<br>of veneers<br>when combined<br>with RelyX<br>Veneer<br>Cement,<br>manufactured<br>by 3M ESPE<br>- Bonding of<br>core build-ups<br>made of light-<br>curing<br>composite or<br>core build-up<br>materials<br>- Bonding of<br>dual-cure<br>cements and<br>core build-up<br>materials and<br>self-cure<br>composites<br>when combined<br>with Activator<br>EXL 760<br>- Repair of<br>composite or<br>compomer<br>fillings<br>- Intraoral<br>repair of<br>composite<br>restorations,<br>porcelain fused<br>to metal, and<br>all-ceramic<br>restorations<br>without extra<br>primer<br>- Root surface<br>desensitization<br>- Sealing of<br>cavities prior to<br>cementation of<br>amalgamate<br>restorations<br>- Sealing of<br>cavities and<br>preparation of<br>tooth stumps<br>prior to<br>temporary | with light- and<br>dual-curing<br>luting<br>composites.<br>- Sealing of<br>prepared<br>tooth surfaces<br>before<br>temporary /<br>permanent<br>cementation<br>of indirect<br>restorations.<br>-<br>Desensitizatio<br>n of<br>hypersensitive<br>cervical areas. | |
| *Only for<br>Ambar<br>Universal APS:<br>Use as metallic<br>or ceramic<br>primer. | | | | |
| | | | cementation of<br>indirect<br>restorations<br>- Bonding of<br>fissure sealants<br>- Protective<br>varnish for<br>glass ionomer<br>fillings<br>- Surface<br>treatment of<br>porcelain,<br>ceramics<br>(including glass<br>ceramics,<br>zirconia and<br>alumina),<br>metal and<br>composite. | |
| How the<br>device<br>achieves its<br>intended<br>purpose | Adhesive<br>Material is a<br>light-curing,<br>single-<br>component<br>dental adhesive<br>for direct and<br>indirect<br>bonding<br>procedures and<br>etching<br>techniques.<br>With total etch<br>adhesives the<br>mineral phase<br>of enamel and<br>dentin is<br>superficially<br>demineralized<br>by an acidic<br>agent (if<br>necessary) in a<br>separate step<br>prior to<br>application of<br>the adhesive.<br>The acid used<br>is typically | Adhesive<br>Material is a<br>light-curing,<br>single-<br>component<br>dental adhesive<br>for direct and<br>indirect bonding<br>procedures and<br>etching<br>techniques.<br>With total etch<br>adhesives the<br>mineral phase of<br>enamel and<br>dentin is<br>superficially<br>demineralized by<br>an acidic agent<br>(if necessary) in<br>a separate step<br>prior to<br>application of the<br>adhesive. The<br>acid used is<br>typically<br>phosphoric acid<br>35-37%. | Adhesive<br>Material is a<br>light-curing,<br>single-<br>component<br>dental adhesive<br>for direct and<br>indirect<br>bonding<br>procedures and<br>etching<br>techniques.<br>With total etch<br>adhesives the<br>mineral phase<br>of enamel and<br>dentin is<br>superficially<br>demineralized<br>by an acidic<br>agent (if<br>necessary) in a<br>separate step<br>prior to<br>application of<br>the adhesive.<br>The acid used<br>is typically | Adhesive<br>Material is a<br>light-curing,<br>single-<br>component<br>dental<br>adhesive for<br>direct and<br>indirect<br>bonding<br>procedures<br>and etching<br>techniques.<br>With total etch<br>adhesives the<br>mineral phase<br>of enamel and<br>dentin is<br>superficially<br>demineralized<br>by an acidic<br>agent (if<br>necessary) in<br>a separate<br>step prior to<br>application of<br>the adhesive.<br>The acid used<br>is typically |
| | phosphoric acid<br>35-37%. | phosphoric acid<br>35-37%. | phosphoric acid<br>35-37%. | phosphoric acid 35-37%. |
| Side effects: | The adhesive<br>can cause<br>sensitization<br>reactions in<br>patients who<br>are sensitive to<br>any<br>components of<br>the formula. In<br>this case, the<br>material should<br>not be used. | The adhesive can<br>cause<br>sensitization<br>reactions in<br>patients who are<br>sensitive to any<br>components of<br>the formula. In<br>this case, the<br>material should<br>not be used. | The adhesive<br>can cause<br>sensitization<br>reactions in<br>patients who<br>are sensitive to<br>any<br>components of<br>the formula. In<br>this case, the<br>material should<br>not be used. | The adhesive<br>can cause<br>sensitization<br>reactions in<br>patients who<br>are sensitive<br>to any<br>components of<br>the formula.<br>In this case,<br>the material<br>should not be<br>used. |
| Primary<br>Package<br>Container: | Vial | Unit dose or vial | Unit dose or<br>vial | VivaPen® and<br>Vial |
| Shelf life | Up to 3 years | Up to 3 years | 2 years | Not found |
| Claims on<br>product<br>performance<br>and safety | Is a light-curing<br>adhesive for<br>bonding<br>restorative<br>materials to<br>dental tissue<br>(enamel and/or<br>dentin). | Is a light-curing<br>adhesive for<br>bonding<br>restorative<br>materials to<br>dental tissue<br>(enamel and/or<br>dentin). | Is a light-<br>curing adhesive<br>for bonding<br>restorative<br>materials to<br>dental tissue<br>(enamel and/or<br>dentin). | Is a light-<br>curing<br>adhesive for<br>bonding<br>restorative<br>materials to<br>dental tissue<br>(enamel<br>and/or<br>dentin). |
| Use the same<br>materials or<br>substances in<br>contact with<br>the same<br>human<br>tissues<br>or body<br>fluids? | YES | YES | YES | YES |
| Is the<br>product in<br>compliance to<br>EN ISO<br>10993? | YES | YES | YES | YES |
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Image /page/9/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a muted blue-gray color. Three horizontal wavy lines are placed within the upper part of the "D", suggesting movement or flow. Below the "D", the word "DentsCare" is written in a simple, sans-serif font, also in the same muted blue-gray color.
DENTSCARE LTDA
AV. EDGAR NELSON MEISTER, 474, JOINVILLE,
SANTA CATARINA 89219-501 BRAZIL DentsCare ph: 55 - 47 - 3441-6131
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Image /page/10/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color. Three horizontal lines are placed inside the "D" to the left. The text "DentsCare" is written below the "D" in a sans-serif font.
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE,
SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
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Image /page/11/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter 'D' in gray, with three horizontal lines emanating from the left side of the 'D', resembling sound waves or air currents. Below the 'D' is the text 'DentsCare' in a sans-serif font, also in gray. The overall design is clean and modern.
DENTSCARE LTDA
AV. EDGAR NELSON MEISTER, 474, JOINVILLE,
SANTA CATARINA 89219-501 BRAZIL DentsCare Ph: 55 - 47 - 3441-6131
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Image /page/12/Picture/0 description: The image contains the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with three horizontal lines inside it, along with the name 'DentsCare' written below. The contact information includes the company's address on AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and their phone number: 55-47-3441-6131.
| Tissues | Enamel and<br>Dentin | Enamel and<br>Dentin | Enamel and<br>Dentin | Enamel and<br>Dentin |
|-------------------------------------------------------------------------------------|----------------------|----------------------|----------------------|----------------------|
| Reusable | NO | NO | NO | NO |
| Duration | Permanent | Permanent | Permanent | Permanent |
| Part of body | Oral, tooth | Oral, tooth | Oral, tooth | Oral, tooth |
| Is it used for<br>the same<br>clinical<br>condition? | YES | YES | YES | YES |
| Is it used at<br>the same site<br>in the body? | YES | YES | YES | YES |
| Is it used in a<br>similar<br>population? | YES | YES | YES | YES |
| Is it used for<br>the same<br>intended<br>purpose? | YES | YES | YES | YES |
| Is not<br>foreseen to<br>deliver<br>significantly<br>different<br>performances<br>? | NO | NO | NO | NO |
| Is it similar<br>conditions of<br>use? | YES | YES | YES | YES |
| Is it similar<br>specifications<br>and<br>properties | YES | YES | YES | YES |
| Is it similar<br>principles of<br>operation? | YES | YES | YES | YES |
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Image /page/13/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" with horizontal lines inside it, above the word "DentsCare" in a stylized font. To the right of the logo is the text "DENTSCARE AV. E SANTA Ph: 5".
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, A CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
| Adhesive<br>Strength<br>(MPa) | Ambar APS<br>38,61 ± 1,68<br>Ambar<br>Universal APS<br>38,02 ± 3,33 | 26,20 ± 2,19 | 34,47 ± 3,34 | 33,27 ± 3,91 |
|---------------------------------|-----------------------------------------------------------------------|---------------|---------------|---------------|
| Conversion<br>rate | Ambar APS<br>53,8 ± 0,5<br>Ambar<br>Universal APS<br>55,80 ± 0,5 | 43,5 ± 1,3 | 55,60 ± 0,5 | 45,07 ± 0,6 |
| Shear bond<br>strength<br>(MPa) | Ambar APS<br>22,21 ± 2,33<br>Ambar<br>Universal APS<br>16,30 ± 1,67 | 20,06 ± 2,52 | 16,97 ± 1,83 | 11,91 ± 1,39 |
| pH | Ambar APS<br>3,16 ± 0,02<br>Ambar<br>Universal APS<br>2,97 ± 0,04 | 4,69 ± 0,03 | 3,28 ± 0,19 | Not performed |
| Viscosity<br>(mPa.s) | Ambar APS<br>81,33 ± 2,05<br>Ambar<br>Universal APS<br>99,20 ± 0,40 | Not performed | Not performed | Not performed |
| Water<br>sorption<br>(µg/mm³) | Ambar APS<br>140,80 ± 1,60<br>Ambar<br>Universal APS<br>145,53 ± 3,12 | 150,76 ± 2,26 | 148,38 ± 2,28 | Not performed |
| Water<br>solubility<br>(µg/mm³) | Ambar APS<br>64,61 ± 1,86<br>Ambar<br>Universal APS<br>64,71 ± 1,59 | 63,29 ± 2,59 | 71,24 ± 5,54 | Not performed |
## Discussion:
The subject device is similar to the predicate devices in that they are all dental adhesives for promoting union between tooth structure (enamel and dentin) and restorative materials.
Despite differences in results, the subject device demonstrates substantial equivalence to the declared predicates, since all products meet ISO 29022 and the results match
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Image /page/14/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with three horizontal lines inside. The text includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).
the requirements of this International Standard and it does not affect the substantial equivalence.
- Adhesive Strength: The average of the results of the adhesive under analysis is ≥ the average of the internationally renowned brand analyzed in this study.
The bond tensile strength exhibits slightly higher values than shear bond strength. Although there is no minimum tensile bond strength value, 20 MPa or more has been proposed as a reasonable value and a goal to be achieved.
By the results obtained, all the adhesives analyzed presented satisfactory results, with slightly higher values obtained by Dentscare adhesives.
The performance of Ambar APS and Ambar Universal APS satisfactorily met the requirements to support substantial equivalence to the predicate.
- Conversion rate: The average of the results of the adhesive under analysis is > the average of the internationally renowned brand analyzed in this study.
The dental compounds basically consist of a mixture of monomers, filler particles, photoinitiator system, inhibitors and dyes. The monomers have methacrylic groups with the carbon double bond, which are photoactivated, form along several polymer chains. The amount of monomers which are converted into polymers represent the major part of the final product, having a lower volume and a smaller amount of free monomers which can be leachable. An analysis of the volume of data is done by analyzing the amount of duplications that have been disrupted, indicating an expression of polymer chains. The higher the conversation rate values, better the results and efficacy of the final product.
By the results obtained, Ambar APS and Ambar Universal APS have presented the highest values, obtaining a higher efficiency of the final product when compared to the predicate. Thus, the results support substantial equivalence to the predicate.
- Shear bond strength: The average of the results of the adhesive under analysis is ≥ the average of the internationally renowned brands analyzed in this study.
The evaluation of the bonding efficiency between an adhesive and the dentin region is usually analyzed by bond strength between bonded specimens in shear or traction until fracture occurs. There is a wide variability of values (deviation) related to several factors such as water content in the dentin, cleaning of the "Smear Layer", orientation of the dentinal tubules.
The enamel structure has a high content of inorganic material (mineral hydroxyapatite) and low amount of organic material such as collagen, thus presenting a lower water content and facilitating adhesive bonding. However in dentine the amount of organic material is higher and, therefore, the humidity is also higher. As the restorative material is hydrophobic and the dentin is hydrophilic, the adhesive system has to be such that it can match both materials, thus, it must have an amphiphilic characteristic.
In summary, the higher the shear bond values, generally for bonding to the enamel, and bonding by traction, generally for adhesion to the dentin structure, the greater the effectiveness of the adhesive system.
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Image /page/15/Picture/0 description: The image contains the logo and contact information for DentsCare LTDA. The logo features a stylized letter D with wave-like lines inside. The contact information includes the address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and the phone number: Ph: 55 - 47 - 3441-6131.
The shear bond strength is one of the indicative of adhesive performance, indicating the shear strength between the tooth / adhesive / restorative interface. In enamel indicates the union effectiveness of an orthodontic cement, for example.
The higher the shear strength or tensile strength values, the greater the effectiveness of the product.
- pH: The pH test is not contemplated in standards for adhesives, however, it is known that 7th generation adhesives must have low hydrogen potential, thus performing the role of acid conditioning.
The average of the results for pH of the adhesive under analysis demonstrate that the subject devices have lower hydrogen potential than the average of the internationally renowned brands analyzed in this study.
- Viscosity: The viscosity property is not contemplated in regulations for adhesives. This aspect does not have impact the in the performance of the product. For this reason, the predicate devices do not refer to viscosity of the product as a quality aspect.
- Water sorption and Water solubility: The results show that the subject devices presented Sorption and Solubility similar to the competing adhesives under analysis. There is no specific standard for sorption and solubility testing on adhesives, so we follow the testing methodology established in ISO 4049 and as an approval criterion we define that the results of our adhesives should be better or statistically equal to competitors of recognized quality on market. ISO 4049 reference values have not been taken into account, assuming that the adhesive class is not covered by this standard.
Conclusion: From the results obtained, the subject devices, Ambar APS and Ambar Universal APS demonstrate equivalent indications for use, shelf life, physical, technical and mechanical properties.
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Image /page/16/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a dark gray color. Inside the "D", there are three horizontal lines that resemble waves. Below the symbol, the word "DentsCare" is written in a sans-serif font, also in dark gray.
R NELSON MEISTER, 474, JOINVILLE, ARINA 89219-501 BRAZIL 47 - 3441-6131
#### L) Applicable Standards:
In order to meet international requirements the device Ambar APS and Ambar Universal APS was developed, as well produced in compliance with recognized international requlations and standards for the medical device industry.
ISO 29022 - Dentistry - Adhesion - Notched edge shear bond strength test
ISO 10993-1 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ENISO 10993-1:2009)
ISO 10993-3 - Biological Evaluation of Medical Devices - Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity.
ISO 10993-5 - Biological Evaluation of Medical Devices - Tests for In vitro Cytotoxicity. ISO 10993-10 - Biological Evaluation of Medical Device – Tests for Irritation and Skin Sensitization.
ISO 10993-11 - Biological Evaluation of Medical Devices - Tests for Systemic Toxicity.
## Conclusion:
Based on compliance with the international standard and regulation mentioned above, the device Ambar APS and Ambar Universal APS demonstrate substantial equivalence to the predicates.
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Image /page/17/Picture/0 description: The image shows the logo for DentsCare. The logo consists of a stylized letter D with three horizontal lines inside it, followed by the text "DentsCare". To the right of the logo is the text "AV. EDGAR", "SANTA CAT", and "Ph: 55 - 47".
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
## M) Non-clinical Testing:
In order to study the performance of the product, pre-clinical tests were performed according to the table below, for details about test results please see attachment 01.
| Test | Specification | Resul…
