Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
Device Facts
| Record ID | K231696 |
|---|---|
| Device Name | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal |
| Applicant | Prevest Denpro Limited |
| Product Code | KLE · Dental |
| Decision Date | Aug 11, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3200 |
| Device Class | Class 2 |
Indications for Use
Fusion Bond 5 is indicated for direct composite or compomer restorations, adhesive cementation, and composite repair. Fusion Bond 7 is indicated for bonding of composites to tooth structure, core build up, and adhesive cementation of crown & bridges, including inlays and onlays. Fusion Bond DC is indicated for direct light cure composite or compomer restorations, core build up, and adhesive cementation of crown & bridges, including inlays and onlays. Renew MDP is indicated for bonding of dual cure, light cure or self cure composite or compomer restorations to tooth structure. treatment of hypersensitive teeth, and intraoral repairs of fractured restorations. Renew Universal is indicated for direct bonding of light-cured compomers to tooth structure, bonding of dual-cured core build up composites to tooth structure as long as these materials are light-cured. intraoral repair of composite, metal-based and zirconia /alumina-based restorations, intraoral repair of ceramic restorations in combination with a silane coupling agent, treatment of hypersensitive teeth, and cavity sealing as a pretreatment for indirect restorations.
Device Story
Dental bonding agents; single-component or two-component (bonding agent + activator) systems; used by dentists in clinical settings. Function: prime and bond restorative materials (composites, compomers, amalgams, porcelains) to tooth structure (enamel/dentin). Application: involves etching (phosphoric acid) and light-curing or dual-curing. Benefits: facilitates adhesion of restorations, core build-ups, and repairs; treats hypersensitivity. Output: chemical bond between tooth and restorative material. Healthcare providers apply agents to prepared tooth surfaces to ensure retention and sealing of restorations.
Clinical Evidence
Bench testing only. Performance evaluated via shear bond strength and curing time testing per ISO 29022:2013. Results demonstrate compliance with standards, with bond strengths ranging from 10 MPa to 25 MPa depending on the specific agent. Shelf life validated through protocols consistent with predicate/reference devices.
Technological Characteristics
Resin-based dental bonding agents; compositions include Bis-GMA, UDMA, TEGDMA, HEMA, and functional monomers (10-MDP, 4-META). Curing via light-cure or dual-cure mechanisms (camphorquinone/amine initiators). Testing per ISO 29022:2013. Formulated as single-bottle or two-component systems. Shelf life 2-3 years.
Indications for Use
Indicated for dental patients requiring direct/indirect restorations, core build-ups, adhesive cementation, intraoral repairs of fractured restorations (composite, metal, zirconia/alumina, ceramic), and treatment of hypersensitive teeth.
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
Reference Devices
- Adhese Universal (K133318)
- XP Bond Dual Cure Universal Total Etch Adhesive (K070538)
- Cal LC (K212457)
- Adper Prompt (K060684)
- Adhese Universal DC (K210804)
- Gluma Comfort Bond (K992985)
Submission Summary (Full Text)
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August 11, 2023
Prevest Denpro Limited % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172
Re: K231696
Trade/Device Name: Fusion Bond 7, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: May 22, 2023 Received: June 12, 2023
Dear Angela Blackwell:
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.
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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 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-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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, Michael E. Adjodha -2
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known) K231696
Device Name
Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
### Indications for Use (Describe)
Fusion Bond 5 is indicated for direct composite or compomer restorations, adhesive cementation, and composite repair.
Fusion Bond 7 is indicated for bonding of composites to tooth structure, core build up, and adhesive cementation of crown & bridges, including inlays and onlays.
Fusion Bond DC is indicated for direct light cure composite or compomer restorations, core build up, and adhesive cementation of crown & bridges, including inlays and onlays.
Renew MDP is indicated for bonding of dual cure, light cure or self cure composite or compomer restorations to tooth structure. treatment of hypersensitive teeth, and intraoral repairs of fractured restorations.
Renew Universal is indicated for direct bonding of light-cured compomers to tooth structure, bonding of dual-cured core build up composites to tooth structure as long as these materials are light-cured. intraoral repair of composite, metal-based and zirconia /alumina-based restorations, intraoral repair of ceramic restorations in combination with a silane coupling agent, treatment of hypersensitive teeth, and cavity sealing as a pretreatment for indirect restorations.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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#### K231696
# Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal 510(k) Summary August 9, 2023
# Name and Address: Prevest Denpro Limited Unit II, Export Promotion Industrial Park Bari Brahmana, Jammu 181133 India Contact Person: Atul Modi Email: prevestindia@gmail.com Telephone: (941) 919 4280
Name of device: Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal Trade Name: Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal Common Name: dental bonding agent Classification Name: Resin tooth bonding agents CFR: 21 CFR 872.3200 Primary Product Code: KLE Regulatory Class: II
## Submission Contact:
Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com
#### Device Description:
Prevest Denpro Tooth Bonding Agents attach different types of restorations to teeth.
Fusion Bond 5 is a light curing single component bonding agent. It primes and bonds in one step to attach restorations of composites, copomers, amalgams, and porcelains to tooth structures. Tooth structures should have a 37% phosphoric acid etchant application of Fusion Bond 5.
Fusion Bond 7 is a light curing single component bonding agent. It etches, primes, and bonds in one step to attach restorations of composites, copomers, amalgams, and porcelains to tooth structures.
Fusion Bond DC is a dual cure bonding direct and indirect restorations. Enamel and dentin surfaces should be conditioned with 37% phosphoric acid etchant before application of Fusion Bond DC. It is a two component adhesive with bonding agent and activator.
Renew MDP is a light curing single component bondines etching, priming and bonding in one bottle. It is an ethanol-water based dental adhesive containing 10-Methacryloyloxydececyl Dihydrogen Phosphate (10-MDP) a functional monomer which helps in bonding to dentin and cut and un-cut enamel. Renew MDP works with light-cured and dual-cured composite materials.
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Renew Universal is a light curing single component bondines etching, priming and bonding. Renew Universal contains a combination of functional monomers such as 10-MDP and 4-META. Renew Universal works with light-cured and dual-cured composite materials.
| Device Name | Indications |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fusion Bond 5 | Fusion Bond 5 is indicated for direct composite or<br>compomer restorations, adhesive cementation,<br>and composite repair. |
| Fusion Bond 7 | Fusion Bond 7 is indicated for bonding of<br>composites to tooth structure, core build up, and<br>adhesive cementation of crown & bridges,<br>including inlays and onlays. |
| Fusion Bond DC | Fusion Bond DC is indicated for direct light cure<br>composite or compomer restorations, core build<br>up, and adhesive cementation of crown &<br>bridges, including inlays and onlays. |
| Renew MDP | Renew MDP is indicated for bonding of dual cure,<br>light cure or self cure composite or compomer<br>restorations to tooth structure, treatment of<br>hypersensitive teeth, and intraoral repairs of<br>fractured restorations. |
| Renew Universal | Renew Universal is indicated for direct bonding of<br>light-cured composites, and compomers to tooth<br>structure, bonding of dual-cured core build up<br>composites to tooth structure as long as these<br>materials are light-cured, intraoral repair of<br>composite, metal-based and zirconia /alumina-<br>based restorations, intraoral repair of ceramic<br>restorations in combination with a silane coupling<br>agent, treatment of hypersensitive teeth, and<br>cavity sealing as a pretreatment for indirect<br>restorations. |
## Indications for Use:
## Testing Summary:
Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP and Renew Universal were tested for appearance, shear bond strength and curing time according to protocols based on ISO 29022:2013.
All test results met the criteria in standard.
Shelf life for Fusion Bond 5 and Fusion Bond 7 is 3 years. Shelf life for Fusion Bond DC, Renew MDP and Renew Universal is 2 years. All shelf life determinations use the same testing protocols as the characterization testing which are based on ISO 29022:2013. The predicate and reference devices use the same ISO standard for their testing. Their shelf lives are 3 years or are not given.
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Primary Predicate Device: Prolink and Prolink SE K110403 from SIlmet
Additional Predicate Devices: Clearfil Photo Bond K943165 and Clearfil SE Bond 2 K131432 from Kuraray
## Reference Devices Used for Ingredients:
Fusion Bond 5 - Adhese Universal (K133318) XP Bond Dual Cure Universal Total Etch Adhesive (K070538) Cal LC (K212457) Fusion Bond 7 - Adper TM Prompt TM (K060684) Adhese Universal (K133318) Adhese Universal DC-
(K210804) XP Bond Dual Cure Universal Total Etch Adhesive (K070538) Cal LC (K212457) Fusion Bond DC - XP Bond Dual Cure Universal Total Etch Adhesive (K070538) Cal LC (K212457) Renew MDP - Adhese Universal (K133318) Cal LC (K212457)
Renew Universal - Adhese Universal (K133318) Gluma Comfort Bond (K992985) Cal LC (K212457)
## Substantial Equivalence:
The bonding agents have similar ingredients to the predicate and reference devices, the same indications for use, and similar physical parameter testing.
| | Fusion Bond 5 | Prolink K110403 from Silmet<br>Predicate Device |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Code | KLE | KLE |
| Indications<br>for Use | Fusion Bond 5 is indicated for<br>direct composite or compomer<br>restorations, adhesive<br>cementation, and composite<br>repair. | Direct Composite or Compomer<br>restorations<br>Adhesive cementation<br>Composite repair |
| Mechanism<br>of Action | Bond restorations to teeth. | Bond restorations to teeth. |
| Applicable<br>Standards | ISO 29022 - Dentistry - Adhesive –<br>Notched-edge shear bond<br>strength test | ISO 29022 - Dentistry - Adhesive –<br>Notched-edge shear bond<br>strength test |
| Compositio<br>n | Bisphenol A Glycidyl<br>MethacrylateEthoxylated Bisphenol A<br>DimethacrylateUrethane DimethacrylateTriethylene Glycol<br>Dimethacrylate2-Hydroxethylmethyl<br>acrylateCamphorquinoneEthyl-4 Di methyl amino<br>benzoateTertiary butanol | Bisphenol diglycidyl<br>methacrylateEthoxylated Bisphenol A<br>DimethacrylateUrethane DimethacrylateTriethylene Glycol<br>Dimethacrylate2-Hydroxethylmethyl<br>acrylatecamphoroquinoneEthyl-4 Di methyl amino<br>benzoateEthanol |
### Resin Tooth Bonding Agents from Prevest Denpro
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| | Butylated hydroxy toluene (BHT) 2-dimethyl amino ethyl Methyacrylate | Acetone |
|------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------|
| Shear Bond<br>Strength | Complies with ISO 29022<br>10 MPA | Complies with ISO 29022<br>14 MPa |
| Curing<br>Time | Complies with ISO 29022<br>20-30 sec | Complies with ISO 29022<br>20 sec |
| Shelf Life | 3 years | Not identified in 510k summary,<br>package information says 3 years |
| | Fusion Bond 7 | Prolink SE K110403 from Silmet<br>Predicate Device |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | KLE | KLE |
| Indications for Use | Fusion Bond 7 is indicated for<br>bonding of composites to<br>tooth structure, core build up,<br>and adhesive cementation of<br>crown & bridges, including<br>inlays and onlays. | Bonding of composites to tooth<br>structure<br>Core Build up<br>Adhesive cementation of crown<br>& bridges, including inlays and<br>onlays |
| Mechanism of Action | Bond restorations to teeth. | Bond restorations to teeth. |
| Composition | Bisphenol A Glycidyl<br>Methacrylate Ethoxylated<br>Bisphenol A<br>Dimethacrylate Urethane<br>Dimethacrylate Triethylene Glycol<br>Dimethacrylate Hydroxethylmethyl<br>Phosphate Camphorquinone Ethyl-4 Di methyl<br>amino benzoate Tertiary butanol Butylated hydroxy<br>toluene (BHT) 2-dimethyl amino<br>ethyl Methyacrylate | Bisphenol diglycidyl<br>methacrylate Ethoxylated Bisphenol A<br>Dimethacrylate Urethane Dimethacrylate Triethylene Glycol<br>Dimethacrylate 2-Hydroxethylmethyl<br>acrylate camphoroquinone Ethyl-4 Di methyl amino<br>benzoate Ethanol Acetone |
| Applicable<br>Standards | ISO 29022 - Dentistry -<br>Adhesive – Notched-edge<br>shear bond strength test | ISO 29022 - Dentistry - Adhesive –<br>Notched-edge shear bond<br>strength test |
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| Shear Bond<br>Strength | Complies with ISO 29022<br>25 MPA | Complies with ISO 29022<br>29MPa |
|------------------------|--------------------------------------|---------------------------------------------------------------------|
| Curing Time | Complies with ISO 29022<br>20-30 sec | Complies with ISO 29022<br>20 sec |
| Shelf Life | 3 years | Not identified in 510k summary,<br>package information says 3 years |
| | Fusion Bond DC | Clearfil Photo Bond K943165<br>from Kuraray<br>Additional Predicate Device | Prolink K110403 from Silmet<br>Predicate Device |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Product<br>Code | KLE | KLE | KLE |
| Indications<br>for Use | Fusion Bond DC is<br>indicated for direct light<br>cure composite or<br>compomer restorations,<br>core build up, and<br>adhesive cementation of<br>crown & bridges,<br>including inlays and<br>onlays. | No 510k database file | Direct Composite or<br>Compomer restorations<br>Adhesive cementation<br>Composite repair |
| Mechanism<br>of Action | Bond restorations to<br>teeth. | Bond restorations to teeth. | Bond restorations to<br>teeth. |
| Composition | Fusion Bond DC Bonding<br>Agent | Universal Liquid: | Bisphenol diglycidyl methacrylate |
| | Bisphenol A Glycidyl Methacrylate | N-N diethyl-p Toludiene | Ethoxylated Bisphenol A Dimethacrylate |
| | Ethoxylated Bisphenol A Dimethacrylate | Sodium benzene sulfinate | Urethane Dimethacrylate |
| | Urethane Dimethacrylate | Ethyl Alcohol | Triethylene Glycol Dimethacrylate |
| | Triethylene Glycol Dimethacrylate | Catalyst Liquid: | 2- Hydroxethylmethyl acrylate |
| | Di Hydroxy Ethyl-P-Toluene | Bisphenol A Glycidyl Methacrylate | camphoroquinone |
| | Camphorquinone | 10- Methacryloyloxydecyl di hydrogen phosphate | Ethyl-4 Di methyl amino benzoate |
| | Ethyl-4 Di methyl amino benzoate | | Ethanol |
| | Tertiary butanol | | Acetone |
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| | Butylated<br>hydroxy toluene<br>(BHT) Fusion Bond DC<br>Activator Bisphenol A<br>Glycidyl<br>Methacrylate Ethoxylated<br>Bisphenol A<br>Dimethacrylate Urethane<br>Dimethacrylate Triethylene<br>Glycol Benzyl Peroxide Tertiary butanol Butylated<br>hydroxy toluene<br>(BHT) | 2-Hydroxethylmethyl<br>acrylate Hydrophobic<br>Dimethacrylate Benzyl Peroxide DL-Camphorquinone | |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Applicable<br>Standards | ISO 29022 - Dentistry -<br>Adhesive - Notched-<br>edge shear bond<br>strength test | ISO 29022 - Dentistry -<br>Adhesive - Notched-edge<br>shear bond strength test | ISO 29022 - Dentistry -<br>Adhesive - Notched-edge<br>shear bond strength test |
| Shear Bond<br>Strength | Complies with ISO 29022<br>19 MPa | Complies with ISO 29022<br>15.9 MPa | Complies with ISO 29022<br>14 MPa |
| Curing Time | Complies with ISO 29022<br>20-30 secs | Complies with ISO 29022<br>10 sec | Complies with ISO 29022<br>20 sec |
| Shelf Life | 2 years | Unknown | Not identified in 510k<br>summary, package<br>information says 3 years |
| | Renew MDP | Prolink K110403 from<br>Silmet<br>Additional Predicate<br>Device | Clearfil SE Bond 2 K131432<br>from Kuraray<br>Predicate Device |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Code | KLE | KLE | KLE |
| Indications<br>for Use | Renew MDP is indicated<br>for bonding of dual cure,<br>light cure or self cure<br>composite or compomer<br>restorations to tooth | Direct Composite or<br>Compomer restorations<br>Adhesive cementation<br>Composite repair | [1] Direct restorations<br>using light-cured<br>composite resin<br>[2] Cavity sealing as a<br>pretreatment for indirect<br>restorations |
| | structure, treatment of<br>hypersensitive teeth, and<br>intraoral repairs of<br>fractured restorations. | | [3] Treatment of exposed<br>root surfaces<br>[4] Treatment of<br>hypersensitive teeth<br>[5] Intraoral repairs of<br>fractured restorations<br>[6] Post cementation using<br>a dual- or self-cured<br>composite resin<br>[7] Core build-ups using a<br>light-, dual- or self-cured<br>core material<br>[8] Cementing inlays,<br>onlays, crowns, bridges<br>and veneers using a<br>composite resin cement |
| Mechanism<br>of Action | Bond restorations to teeth. | Bond restorations to teeth. | Bond restorations to teeth. |
| Composition | Bisphenol A<br>Glycidyl<br>Methacrylate Urethane<br>Dimethacrylate Triethylene Glycol<br>Dimethacrylate 2-<br>Hydroxethylmethyl<br>acrylate Ethanol DL<br>Camphorquinone Ethyl-4 Di methyl<br>amino benzoate Butylated hydroxy<br>toluene (BHT) 2-dimethyl amino<br>ethyl<br>Methyacrylate DM water 10-<br>Methacryloxydecyl<br>Dihydogen<br>Phosphate | Bisphenol<br>diglycidyl<br>methacrylate Ethoxylated<br>Bisphenol A<br>Dimethacrylate Urethane<br>Dimethacrylate Triethylene Glycol<br>Dimethacrylate 2-<br>Hydroxethylmethyl<br>acrylate camphoroquinone Ethyl-4 Di methyl<br>amino benzoate Ethanol Acetone | Bisphenol A<br>Glycidyl<br>Methacrylate 10-<br>Methacryloxydecyl<br>Dihydogen<br>Phosphate 2-<br>Hydroxethylmethyl<br>acrylate Hydrophobic<br>aliphatic<br>dimethacrylate Dimethacrylate<br>monomer dl-<br>Camphorquinone Microfillers Initiators Accelerators |
| Applicable<br>Standards | ISO 29022 - Dentistry -<br>Adhesive - Notched-edge<br>shear bond strength test | ISO 29022 - Dentistry -<br>Adhesive - Notched-edge<br>shear bond strength test | ISO 29022 - Dentistry -<br>Adhesive - Notched-edge<br>shear bond strength test |
| | Complies with ISO 29022 | Complies with ISO 29022 | Complies with ISO 29022 |
| Shear Bond<br>Strength | 21 MPa | 14 MPa | 12.45 MPa or 25-30 MPa |
| Curing Time | 20-30 secs | 20 sec | 10 sec |
| Shelf Life | 2 years | Not identified in 510k<br>summary, package<br>information says 3 years | Not identified in 510k<br>summary, package<br>information says 2 years |
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| | Renew Universal | Prolink K110403 from<br>Silmet<br>Additional Predicate<br>Device | Clearfil SE Bond 2 K131432<br>from Kuraray<br>Predicate Device |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | KLE | KLE | KLE |
| Indications for Use | Renew Universal is<br>indicated for direct<br>bonding of light-cured<br>composites, and<br>compomers to tooth<br>structure, bonding of dual-<br>cured core build up<br>composites to tooth<br>structure as long as these<br>materials are light-cured,<br>intraoral repair of<br>composite, metal-based<br>and zirconia /alumina-<br>based restorations,<br>intraoral repair of ceramic<br>restorations in<br>combination with a silane<br>coupling agent, treatment<br>of hypersensitive teeth,<br>and cavity sealing as a<br>pretreatment for indirect<br>restorations. | Direct Composite or<br>Compomer restorations<br>Adhesive cementation<br>Composite repair | [1] Direct restorations<br>using light-cured<br>composite resin<br>[2] Cavity sealing as a<br>pretreatment for indirect<br>restorations<br>[3] Treatment of exposed<br>root surfaces<br>[4] Treatment of<br>hypersensitive teeth<br>[5] Intraoral repairs of<br>fractured restorations<br>[6] Post cementation using<br>a dual- or self-cured<br>composite resin<br>[7] Core build-ups using a<br>light-, dual- or self-cured<br>core material<br>[8] Cementing inlays,<br>onlays, crowns, bridges<br>and veneers using a<br>composite resin cement |
| Mechanism of Action | Bond restorations to teeth. | Bond restorations to teeth. | Bond restorations to teeth. |
| Composition | Bisphenol A<br>Glycidyl<br>Methacrylate Urethane<br>Dimethacrylate Triethylene Glycol<br>Dimethacrylate | Bisphenol<br>diglycidyl<br>methacrylate Ethoxylated<br>Bisphenol A<br>Dimethacrylate Urethane<br>Dimethacrylate | Bisphenol A<br>Glycidyl<br>Methacrylate 10-<br>Methacryloxydecyl<br>Dihydogen<br>Phosphate |
| | | | |
| | • 2-<br>Hydroxethylmethyl<br>acrylate<br>• Ethanol<br>• DL<br>Camphorquinone<br>• Ethyl-4 Di methyl<br>amino benzoate<br>• Butylated hydroxy<br>toluene (BHT)<br>• 2-dimethyl amino<br>ethyl<br>Methyacrylate<br>• DM water<br>• 4-2-<br>Methacryloxyethyl<br>Trimelltic | • Triethylene Glycol<br>Dimethacrylate<br>• 2-<br>Hydroxethylmethyl<br>acrylate<br>• camphoroquinone<br>• Ethyl-4 Di methyl<br>amino benzoate<br>• Ethanol<br>Acetone | • 2-<br>Hydroxethylmethyl<br>acrylate<br>• Hydrophobic<br>aliphatic<br>dimethacrylate<br>• Dimethacrylate<br>monomer<br>• dl-<br>Camphorquinone<br>• Microfillers<br>• Initiators<br>• Accelerators |
| Applicable<br>Standards | ISO 29022 - Dentistry -<br>Adhesive - Notched-edge<br>shear bond strength test | ISO 29022 - Dentistry -<br>Adhesive - Notched-edge<br>shear bond strength test | ISO 29022 - Dentistry -<br>Adhesive - Notched-edge<br>shear bond strength test |
| Shear Bond<br>Strength | Complies with ISO 29022<br>21 MPa | Complies with ISO 29022<br>14 MPa | Complies with ISO 29022<br>12.45 MPa or 30 MPa |
| Curing Time | Complies with ISO 29022<br>20-30 secs | Complies with ISO 29022<br>20 sec | Complies with ISO 29022<br>10 sec |
| Shelf Life | 2 years | Not identified in 510k<br>summary, package<br>information says 3 years | Not identified in 510k<br>summary, package<br>information says 2 years |
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Conclusion: Prevest Denpro tooth bonding agents are substantially equivalent to the predicate devices Prolink and Prolink SE K110403 from Silmet. They have the same indications, similar testing, and very similar ingredients. Both the subject devices and the predicate device have physical parameters which meet requirements of the relevant ISO standards. Shelf life testing is similar to the shelf life testing of predicate or reference device. Reference devices are included to cover any ingredients, or indications not covered by the predicate devices. Any differences in ingredients are minor and do not change the substantial equivalence.
