Riva Cem Automix
Device Facts
| Record ID | K214118 |
|---|---|
| Device Name | Riva Cem Automix |
| Applicant | Sdi Limited |
| Product Code | EMA · Dental |
| Decision Date | Aug 30, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3275 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Permanent cementation of: 1) Porcelain fused to metal (PFM) to crowns and bridges 2) Prefabricated/cast posts 3) Metals to crowns, bridges, inlays & onlays, orthodontic appliances & posts 4) Ceramics (high strength)* to crowns & bridges, inlays & onlays *E.g. Zirconia, Lithium Disilicate, 5) Ceramics (low strength)* to inlays *E.g. Feldspathic porcelains, Glass ceramics
Device Story
Riva Cem Automix is a radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement. It consists of a base paste and a catalyst paste delivered via a double-barrel automix syringe for consistent mixing. Used by dentists in clinical settings for permanent cementation of various dental restorations (crowns, bridges, inlays, onlays, posts, orthodontic appliances). The device utilizes a dual-curing mechanism: an acid-base reaction between fluoroaluminosilicate glass and polyacrylic acid copolymer, combined with methacrylate monomer polymerization (chemical or light-cure). Light-curing (tack-cure) allows for easier removal of excess cement. The cement provides a mechanical interlock between the restoration and tooth structure. By providing a reliable, versatile bonding agent, the device aids in the long-term retention of dental prosthetics.
Clinical Evidence
No clinical studies were performed. Substantial equivalence is supported by bench testing including working time, setting time, film thickness, flexural strength, radio-opacity, shear bond strength, and fluoride release, conducted per ISO 9917-2, ISO 29022, and ISO/TS 11405. Biocompatibility was verified per ISO 10993-1 and ISO 7405.
Technological Characteristics
Resin-modified glass ionomer luting cement. Two-component paste/paste system. Chemistry: acid-base reaction (fluoroaluminosilicate glass and polyacrylic acid copolymer) and methacrylate polymerization. Includes photoinitiator system for tack-curing (440-480 nm). Delivery: double-barrel automix syringe. Radiopaque. Fluoride-releasing.
Indications for Use
Indicated for permanent cementation of PFM crowns/bridges, prefabricated/cast posts, metal restorations (crowns, bridges, inlays, onlays, orthodontic appliances), and ceramic restorations (high-strength zirconia/lithium disilicate crowns/bridges/inlays/onlays; low-strength feldspathic/glass ceramic inlays). Contraindicated for pulp capping and patients with known resin or methacrylate allergies.
Regulatory Classification
Identification
Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.
Predicate Devices
Submission Summary (Full Text)
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August 30, 2022
SDI Limited Antonella Kotefski Regulatory Affairs Manager 3-15 Brunsdon Street Bayswater, Victoria 3153 AUSTRALIA
Re: K214118
Trade/Device Name: Riva Cem Automix Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: July 29, 2022 Received: August 3, 2022
Dear Antonella Kotefski:
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,
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 Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K214118
Device Name Riva Cem Automix
| Indications for Use ( <i>Describe</i> ) | |
|-----------------------------------------|--|
| Permanent cementation of: | |
- 1) Porcelain fused to metal (PFM) to crowns and bridges
- 2) Prefabricated/cast posts
- 3) Metals to crowns, bridges, inlays & onlays, orthodontic appliances & posts
- 4) Ceramics (high strength)* to crowns & bridges, inlays & onlays
- *E.g. Zirconia, Lithium Disilicate,
- 5) Ceramics (low strength)* to inlays
- *E.g. Feldspathic porcelains, Glass ceramics
| 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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### 1. Submitter Information
| Submitter: | SDI Limited<br>3-15 Brunsdon Street<br>Bayswater, Victoria 3153<br>Australia |
|-----------------|------------------------------------------------------------------------------|
| Contact Person: | Quynh Jewell |
| Position: | Regulatory Affairs Manager |
| Phone: | +61 3 8727 7111 |
| Email: | Quynh.Jewell@sdi.com.au |
24 August 2022 Date Prepared:
### 2. Device Details
| Proprietary Name: | Riva Cem Automix™ |
|--------------------|---------------------------------------------|
| Common Name: | Dental Cement, Resin Modified Glass Ionomer |
| Regulation Name: | Dental Cement |
| Regulation Number: | 21 CFR 872.3275 |
| Product Code: | EMA |
| Regulatory Class: | II |
### Predicate Device 3.
Permanent cementation for the following:
| Primary Predicate Device | 510(k) Device Number | Company Name |
|--------------------------|----------------------|--------------|
| RelyX Luting Plus™ | K111185 | 3M ESPE |
| Secondary Predicate Device | 510(k) Device Number | Company Name |
|----------------------------|----------------------|----------------|
| FujiCEM™ 2 | K182854 | GC Corporation |
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### Device Description 4.
Riva Cem Automix™ is a radiopaque, fluoride releasing, resin modified glass ionomer luting cement.
Riva Cem Automix™ is intended for the cementation of crowns, bridges, inlays, posts (fibre-reinforced), and orthodontic appliances.
Riva Cem Automix™ consists of a base paste and a catalyst paste packaged in the automix delivery system for direct delivery in consistent mix ratios. Riva Cem Automix™ is available in a universal light-yellow shade in a double barrel syringe. The automix tip offers convenience over traditional hand mixed systems.
The product provides both self-cure and tack cure mechanisms which makes it versatile for the cementation of different restorative systems.
### 5. Indications of Use
Permanent cementation of:
| Indicated Material | Type of Restoration |
|--------------------------------|--------------------------------------------------------------------|
| Porcelain fused to metal (PFM) | Crowns & bridges |
| Prefabricated/cast | Posts |
| Metals | Crown, bridges, inlays & onlays, orthodontic appliances<br>& posts |
| Ceramics (high strength)1 | Crowns & bridges, inlays & onlays |
| Ceramics (low strength)2 | Inlays |
1 High strength ceramics, e.g. Zirconia, Lithium Disilicate.
2 Low strength ceramics, e.g. Feldspathic Porcelains, Glass Ceramics.
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### Comparison of Technological Characteristics with the Predicate 6. Device
Luting cements, including resin modified glass ionomer cements, are widely used to cement crowns. Luting cements provide the mechanical interlock between the crown and the other types of restorative materials indicated, and the tooth structure.
Riva Cem Automix™ is identical to predicate devices RelyX™ Luting Plus Automix and FujiCEM™ 2 in terms of technology and delivery.
Two mechanisms provide the bonding between the cement and the tooth structure or restorative material through self-curing and light-curing.
Self-curing the luting cement occurs by an acid-base reaction between the two pastes, as well as polymerisation of the methacrylic polymer.
Light curing also provides the chemical reaction of the two pastes by the photoinitiators in the formulation, enhancing the reaction between the cement and the restorative material.
### Substantial Equivalence
Information provided in this 510(k) submission shows that Riva Cem Automix™ is substantially equivalent to the predicate devices 3M ESPE RelyX™ Luting Plus Automix (K111185) and GC FujiCEM™ 2 Luting Cement (K182854). A comparison of the devices is provided below in Table 1.
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Establishment Registration No: 3004140838
510(k) NOTIFICATION (Traditional): Riva Cem Automix – Summary – July 2022 - K214118
## Table 1 Comparison of Riva Cem Automix™ with the Primary Predicate and Secondary Predicate Devices
| | Submitter Device | Primary Predicate Device | Secondary Predicate Device | Differences |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary<br>Name | Riva Cem AutomixTM<br>(K214118) | RelyXTM Luting Plus Automix<br>(K111185) | FujiCEMTM 2<br>(K182854) | Name |
| Regulation No. | 21 CFR 872.3275 | 21 CFR 872.3275 | 21 CFR 872.3275 | None |
| Product Code | EMA | EMA | EMA | None |
| Regulatory<br>Class | II | II | II | None |
| Rx / OTC | Rx | Rx | Rx | None |
| Regulation<br>Name | Dental cement | Dental cement | Dental cement | None |
| Product<br>Category | Resin Modified Glass Ionomer Luting<br>Cement | Resin Modified Glass Ionomer Luting<br>Cement | Resin Modified Glass Ionomer Luting<br>Cement | None |
| Intended Use | Dental Luting Cement | Dental Luting Cement | Dental Luting Cement | None |
| Application | Paste-paste | Paste-paste | Paste-paste | None |
| Curing | Self-cure, tack cure | Self-cure, tack cure | Self-cure | All are similar.<br>Riva Cem<br>AutomixTM and<br>RelyXTM Luting<br>Plus have optional<br>tack cure. |
| Curing<br>Chemistry | Acid-base and polymerisation<br>reactions | Acid-base and polymerisation<br>reactions | Acid-base and polymerisation<br>reactions | None |
| Indications for<br>Use (IFU) | Permanent cementation of:<br>- Porcelain fused to metal (PFM) to<br>crowns and bridges<br>- Prefabricated/cast posts<br>- Metals to crowns, bridges, inlays &<br>onlays, orthodontic appliances &<br>posts | 510k indications:<br>This device is intended for use as a<br>dental cement.<br>RelyX Luting Plus Automix (Lexus-2)<br>is indicated for Luting:<br>- Luting porcelain fused to metal<br>crowns and bridges to tooth | FujiCEM 2 is indicated for:<br>- Cementation of metal-based inlays,<br>onlays, crowns and bridges<br>- Cementation of resin inlays, onlays,<br>crowns and bridges<br>- Cementation of all ceramic inlays<br>- Cementation of high strength (e.g. | Similar - different<br>wording. See<br>below for<br>comparison of each<br>indication. |
| | Submitter Device | Primary Predicate Device | Secondary Predicate Device | Differences |
| Proprietary<br>Name | Riva Cem AutomixTM<br>(K214118) | RelyXTM Luting Plus Automix<br>(K111185) | FujiCEMTM 2<br>(K182854) | Name |
| | - Ceramics (high strength)* to<br>crowns & bridges, inlays & onlays<br>*E.g. Zirconia, Lithium Disilicate,<br>- Ceramics (low strength)* to inlays<br>*E.g. Feldspathic porcelains, Glass<br>ceramics | structure, amalgam, composite or<br>glass ionomer core build ups;<br>- Luting metal inlays, onlays or<br>crowns;<br>- Luting pre-fabricated and cast post<br>cementation;<br>- Luting orthodontic appliances;<br>- Luting crowns made with all-<br>alumina or all zirconia cores such as<br>Procera All Ceram | zirconia based, lithium disilicate)<br>ceramic onlays, crowns and bridges<br>- Cementation of metal, ceramic and<br>fiber posts | |
| Comparison of<br>IFU | Porcelain fused to metal (PMF) to<br>crowns and bridges | 510k indications:<br>Luting porcelain fused to metal<br>crowns and bridges to tooth<br>structure, amalgam, composite or<br>glass ionomer core build ups; | Cementation of metal-based inlays,<br>onlays, crowns and bridges | None (PFM and<br>metal-based are<br>the same regarding<br>cementation as<br>both consist of<br>metal). |
| | Prefabricated/cast posts | N/A | Cementation of resin inlays, onlays,<br>crowns and bridges<br>Cementation of metal, ceramic and<br>fiber posts | None (except for<br>RelyXTM Luting<br>Plus which it is not<br>indicated) |
| | Metals to crowns, bridges, inlays &<br>onlays, orthodontic appliances &<br>posts | 510k indications:<br>Luting metal inlays, onlays or<br>crowns,<br>Luting orthodontic appliances,<br>Luting prefabricated and cast post<br>cementation | Cementation of metal-based inlays,<br>onlays, crowns and bridges | None |
| | Ceramics (high strength)* to crowns<br>& bridges, inlays & onlays<br>*E.g. Zirconia, Lithium Disilicate | 510k indications:<br>Luting crowns made with all-alumina<br>or all zirconia cores such as Procera | Cementation of high strength (e.g.<br>based, lithium disilicate) ceramic<br>onlays, crowns and bridges | None |
| | Submitter Device | Primary Predicate Device | Secondary Predicate Device | Differences |
| Proprietary<br>Name | Riva Cem AutomixTM<br>(K214118) | RelyXTM Luting Plus Automix<br>(K111185) | FujiCEMTM 2<br>(K182854) | Name |
| | | All Ceram | | |
| | Ceramics (low strength)* - Inlays<br>*E.g. Feldspathic porcelains, Glass<br>ceramics | N/A | Cementation of all ceramic inlays | None (except for<br>RelyXTM Luting<br>Plus which it is not<br>indicated) |
| Light Curing<br>Specification<br>Comparison | The parameters for tack curing are:<br>1. Use a light curing device<br>Wavelength: 440-480 nmIntensity: 1500 mW/cm2<br>[+5% / - 15%]<br>2. Apply for 5 seconds per surface | The parameters for tack curing are:<br>1. Use a light curing device:<br>Wavelength: 430-480 nmIntensity: 1470 mW/cm2<br>[-10% / +20%]<br>2. Apply for 5 seconds per surface. | N/A | Minor differences |
| Contra-<br>indications | 1. Pulp capping<br>2. Product may cause skin irritations<br>to some people. In such cases,<br>discontinue use and seek medical<br>attention. Any persons having known<br>resin allergies should immediately<br>discontinue use | This product contains substances<br>that may cause an allergic reaction<br>by skin contact in certain individuals.<br>Avoid use of the product in patients<br>with known acrylate allergies. | 1. Pulp capping.<br>2. Avoid use of this product in<br>patients with known allergies to glass<br>ionomer cement, methacrylate<br>monomer or methacrylate polymer | None (except for<br>RelyXTM Luting<br>Plus which<br>contraindication for<br>pulp capping is not<br>specified) |
| Technological<br>Characteristics<br>& Mode of<br>Action | A two-component paste/paste<br>system based on:<br>1.An acid-base reaction between<br>fluoroalumino-silicate glass in and<br>polyacrylic acid copolymer.<br>2. Polymerization of methacrylate<br>monomers is through chemical cure<br>or light cure.<br>3. Photoinitiator system: • Tack-<br>curing for excess removal | A two-component paste/paste<br>system.<br>Glass Ionomer Tooth bonding<br>properties based on<br>1. An acid-base reaction between<br>fluoroalumino-silicate glass and<br>methacrylated polycarboxylic acid;<br>2. A free radical polymerization of<br>the methacrylated copolymer and<br>ethylenically unsaturated<br>monomers/agents, through chemical | A two-component paste/paste<br>system.<br>The device is set by acid-base<br>reaction and polymerization after<br>mixing 2 pastes.<br>1. Acid-base reaction occurs<br>between fluoroaluminosilicate glass<br>in Paste A and polyacrylic acid in<br>Paste B.<br>2. Polymerization of methacrylate<br>monomers is through chemical cure. | None. Devices are<br>paste/paste<br>systems which form<br>an acid-base<br>reaction and<br>polymerisation of<br>methacrylate<br>component.<br>Riva Cem<br>AutomixTM and<br>RelyXTM Luting<br>Plus offer a tack |
| | Submitter Device | Primary Predicate Device | Secondary Predicate Device | Differences |
| Proprietary<br>Name | Riva Cem Automix™<br>(K214118) | RelyX™ Luting Plus Automix<br>(K111185) | FujiCEM™ 2<br>(K182854) | Name |
| | The 2 pastes are delivered in a<br>consistent manner through an<br>Automix syringe delivery system. | cure or light cure;<br>3. Photoinitiator system with<br>camphorquinone (CPQ) and 4-<br>(dimethylamino)- phenethyl alcohol<br>(DMAPE): • Tack-curing for excess<br>removal<br>The 2 pastes are delivered in a<br>consistent manner through an<br>automix delivery system | | cure and contain<br>photoinitiators. |
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# SDI Limited
Establishment Registration No: 3004140838
510(k) NOTIFICATION (Traditional): Riva Cem Automix – Summary – July 2022 -K214118
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# SDI Limited
Establishment Registration No: 3004140838
510(k) NOTIFICATION (Traditional): Riva Cem Automix – Summary – July 2022 - K214118
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## SDI Limited
Establishment Registration No: 3004140838
510(k) NOTIFICATION (Traditional): Riva Cem Automix – Summary – July 2022 - K214118
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### Performance Data 7.
The following performance data were provided in support of the substantial equivalence determination.
## Bench testing
The following in-vitro bench tests were performed on Riva Cem Automix™ as per ISO 9917-2 2017 - "Dental water-based cements - Part 2: Resin-modified cements" (Section 5), ISO 29022 - "Dentistry - Adhesive - Notched-edge sheer bond strength test", ISO/TS 11405 -"Dentistry - Testing of adhesion to tooth structure" and an in-house method to verify physical properties and performance in support of substantial equivalence:
- Working time
- . Setting time
- . Film thickness
- . Flexural strength
- . Radio-opacity
- . Shear Bond strength
- Fluoride release
The performance of Riva Cem Automix™ satisfactorily met the requirements of the nonclinical bench testing conducted to support substantial equivalence.
## Biocompatibility testing
Biocompatibility testing was conducted according to ISO 10993-1 - Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and ISO 7405- Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
The results of the biocompatibility testing and composition analysis conducted relating to the subject device Riva Cem Automix™ support its substantial equivalence.
## Clinical Performance Data
No data from human clinical studies has been included to support the substantial equivalence of Riva Cem Automix™.
## Electrical safety and electromagnetic compatibility (EMC)
This section does not apply.
## Software verification and validation testing
This section does not apply.
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## Mechanical and acoustic testing
This section does not apply.
### Animal studies
This section does not apply.
### Clinical studies
No data from human clinical studies has been included to support the substantial equivalence of Riva Cem Automix™ .
#### Conclusion Regarding Substantial Equivalence 8.
Riva Cem AutomixTM has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the primary predicate RelyX Luting Plus and secondary predicate FujiCEM 2. Test data to verify physical properties and the performance of Riva Cem AutomixTM has been provided including working time, setting time, film thickness, flexural strength and radio-opacity on various substrates. The results of the testing, combined with the design and intended use comparison with both predicate devices, RelyX Luting Plus and FujiCEM 2, support substantial equivalence.
