(60 days)
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.
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.
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.
This document describes a 510(k) premarket notification for a series of dental bonding agents manufactured by Prevest Denpro Limited. The purpose of the 510(k) is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical efficacy through a comparative effectiveness study with human readers and AI assistance. Therefore, many of the requested criteria often associated with AI/ML medical devices are not applicable to this submission.
Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are established by the ISO 29022:2013 standard, specifically for "Dentistry - Adhesive - Notched-edge shear bond strength test." The reported device performance is stated as "Complies with ISO 29022" for both shear bond strength and curing time, with specific values provided as well.
| Device Name | Acceptance Criteria (from ISO 29022:2013) | Reported Device Performance (Shear Bond Strength) | Reported Device Performance (Curing Time) |
|---|---|---|---|
| Fusion Bond 5 | Complies with ISO 29022 (Shear Bond Strength) | 10 MPa | 20-30 sec |
| Complies with ISO 29022 (Curing Time) | |||
| Fusion Bond 7 | Complies with ISO 29022 (Shear Bond Strength) | 25 MPa | 20-30 sec |
| Complies with ISO 29022 (Curing Time) | |||
| Fusion Bond DC | Complies with ISO 29022 (Shear Bond Strength) | 19 MPa | 20-30 secs |
| Complies with ISO 29022 (Curing Time) | |||
| Renew MDP | Complies with ISO 29022 (Shear Bond Strength) | 21 MPa | 20-30 secs |
| Complies with ISO 29022 (Curing Time) | |||
| Renew Universal | Complies with ISO 29022 (Shear Bond Strength) | 21 MPa | 20-30 secs |
| Complies with ISO 29022 (Curing Time) |
Note: The document explicitly states "All test results met the criteria in standard." The specific numeric values (e.g., 10 MPa for Fusion Bond 5) are the reported performance, which is implicitly accepted as meeting the standard's criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each test. It states "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."
The data provenance is from Prevest Denpro Limited, located in Bari Brahmana, Jammu 181133 India. The tests are presented as part of a regulatory submission, implying they were prospective tests conducted specifically for this 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is a physical testing submission, not a diagnostic imaging AI/ML device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of medical image interpretation (e.g., radiologists) is not applicable. The ground truth is established by the physical properties measured according to an international standard (ISO 29022:2013).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus among human readers for image interpretation. This submission involves physical, objective measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This is not an AI/ML medical device where human reader performance with and without AI assistance is relevant. This is a dental material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component in these dental bonding agents. The "performance" is the physical properties of the material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the device's performance is based on objective physical measurements conducted according to the ISO 29022:2013 standard for dental adhesives, specifically for shear bond strength and curing time. In essence, the ground truth is the scientific and engineering standard.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of machine learning for this type of device. The products are dental materials, and their formulation and manufacturing are based on established chemical and material science principles, not on iterative training data.
9. How the ground truth for the training set was established
Not applicable. As there is no training set (in the ML sense), there is no ground truth to establish for it. The "ground truth" for the development of these materials would stem from principles of chemistry, material science, and prior knowledge in dental adhesive development.
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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.
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 orcompomer restorations, adhesive cementation,and composite repair. |
| Fusion Bond 7 | Fusion Bond 7 is indicated for bonding ofcomposites to tooth structure, core build up, andadhesive cementation of crown & bridges,including inlays and onlays. |
| Fusion Bond DC | Fusion Bond DC is indicated for direct light curecomposite or compomer restorations, core buildup, and adhesive cementation of crown &bridges, including inlays and onlays. |
| Renew MDP | Renew MDP is indicated for bonding of dual cure,light cure or self cure composite or compomerrestorations to tooth structure, treatment ofhypersensitive teeth, and intraoral repairs offractured restorations. |
| Renew Universal | Renew Universal is indicated for direct bonding oflight-cured composites, and compomers to toothstructure, bonding of dual-cured core build upcomposites to tooth structure as long as thesematerials are light-cured, intraoral repair ofcomposite, metal-based and zirconia /alumina-based restorations, intraoral repair of ceramicrestorations in combination with a silane couplingagent, treatment of hypersensitive teeth, andcavity sealing as a pretreatment for indirectrestorations. |
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 SilmetPredicate Device | |
|---|---|---|
| ProductCode | KLE | KLE |
| Indicationsfor Use | Fusion Bond 5 is indicated fordirect composite or compomerrestorations, adhesivecementation, and compositerepair. | Direct Composite or CompomerrestorationsAdhesive cementationComposite repair |
| Mechanismof Action | Bond restorations to teeth. | Bond restorations to teeth. |
| ApplicableStandards | ISO 29022 - Dentistry - Adhesive –Notched-edge shear bondstrength test | ISO 29022 - Dentistry - Adhesive –Notched-edge shear bondstrength test |
| Composition | Bisphenol A GlycidylMethacrylateEthoxylated Bisphenol ADimethacrylateUrethane DimethacrylateTriethylene GlycolDimethacrylate2-HydroxethylmethylacrylateCamphorquinoneEthyl-4 Di methyl aminobenzoateTertiary butanol | Bisphenol diglycidylmethacrylateEthoxylated Bisphenol ADimethacrylateUrethane DimethacrylateTriethylene GlycolDimethacrylate2-HydroxethylmethylacrylatecamphoroquinoneEthyl-4 Di methyl aminobenzoateEthanol |
Resin Tooth Bonding Agents from Prevest Denpro
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| Butylated hydroxy toluene (BHT) 2-dimethyl amino ethyl Methyacrylate | Acetone | |
|---|---|---|
| Shear BondStrength | Complies with ISO 2902210 MPA | Complies with ISO 2902214 MPa |
| CuringTime | Complies with ISO 2902220-30 sec | Complies with ISO 2902220 sec |
| Shelf Life | 3 years | Not identified in 510k summary,package information says 3 years |
| Fusion Bond 7 | Prolink SE K110403 from SilmetPredicate Device | |
|---|---|---|
| Product Code | KLE | KLE |
| Indications for Use | Fusion Bond 7 is indicated forbonding of composites totooth structure, core build up,and adhesive cementation ofcrown & bridges, includinginlays and onlays. | Bonding of composites to toothstructureCore Build upAdhesive cementation of crown& bridges, including inlays andonlays |
| Mechanism of Action | Bond restorations to teeth. | Bond restorations to teeth. |
| Composition | Bisphenol A GlycidylMethacrylate EthoxylatedBisphenol ADimethacrylate UrethaneDimethacrylate Triethylene GlycolDimethacrylate HydroxethylmethylPhosphate Camphorquinone Ethyl-4 Di methylamino benzoate Tertiary butanol Butylated hydroxytoluene (BHT) 2-dimethyl aminoethyl Methyacrylate | Bisphenol diglycidylmethacrylate Ethoxylated Bisphenol ADimethacrylate Urethane Dimethacrylate Triethylene GlycolDimethacrylate 2-Hydroxethylmethylacrylate camphoroquinone Ethyl-4 Di methyl aminobenzoate Ethanol Acetone |
| ApplicableStandards | ISO 29022 - Dentistry -Adhesive – Notched-edgeshear bond strength test | ISO 29022 - Dentistry - Adhesive –Notched-edge shear bondstrength test |
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| Shear BondStrength | Complies with ISO 2902225 MPA | Complies with ISO 2902229MPa |
|---|---|---|
| Curing Time | Complies with ISO 2902220-30 sec | Complies with ISO 2902220 sec |
| Shelf Life | 3 years | Not identified in 510k summary,package information says 3 years |
| Fusion Bond DC | Clearfil Photo Bond K943165from KurarayAdditional Predicate Device | Prolink K110403 from SilmetPredicate Device | |
|---|---|---|---|
| ProductCode | KLE | KLE | KLE |
| Indicationsfor Use | Fusion Bond DC isindicated for direct lightcure composite orcompomer restorations,core build up, andadhesive cementation ofcrown & bridges,including inlays andonlays. | No 510k database file | Direct Composite orCompomer restorationsAdhesive cementationComposite repair |
| Mechanismof Action | Bond restorations toteeth. | Bond restorations to teeth. | Bond restorations toteeth. |
| Composition | Fusion Bond DC BondingAgent | 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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| Butylatedhydroxy toluene(BHT) Fusion Bond DCActivator Bisphenol AGlycidylMethacrylate EthoxylatedBisphenol ADimethacrylate UrethaneDimethacrylate TriethyleneGlycol Benzyl Peroxide Tertiary butanol Butylatedhydroxy toluene(BHT) | 2-Hydroxethylmethylacrylate HydrophobicDimethacrylate Benzyl Peroxide DL-Camphorquinone | ||
|---|---|---|---|
| ApplicableStandards | ISO 29022 - Dentistry -Adhesive - Notched-edge shear bondstrength test | ISO 29022 - Dentistry -Adhesive - Notched-edgeshear bond strength test | ISO 29022 - Dentistry -Adhesive - Notched-edgeshear bond strength test |
| Shear BondStrength | Complies with ISO 2902219 MPa | Complies with ISO 2902215.9 MPa | Complies with ISO 2902214 MPa |
| Curing Time | Complies with ISO 2902220-30 secs | Complies with ISO 2902210 sec | Complies with ISO 2902220 sec |
| Shelf Life | 2 years | Unknown | Not identified in 510ksummary, packageinformation says 3 years |
| Renew MDP | Prolink K110403 fromSilmetAdditional PredicateDevice | Clearfil SE Bond 2 K131432from KurarayPredicate Device | |
|---|---|---|---|
| ProductCode | KLE | KLE | KLE |
| Indicationsfor Use | Renew MDP is indicatedfor bonding of dual cure,light cure or self curecomposite or compomerrestorations to tooth | Direct Composite orCompomer restorationsAdhesive cementationComposite repair | [1] Direct restorationsusing light-curedcomposite resin[2] Cavity sealing as apretreatment for indirectrestorations |
| structure, treatment ofhypersensitive teeth, andintraoral repairs offractured restorations. | [3] Treatment of exposedroot surfaces[4] Treatment ofhypersensitive teeth[5] Intraoral repairs offractured restorations[6] Post cementation usinga dual- or self-curedcomposite resin[7] Core build-ups using alight-, dual- or self-curedcore material[8] Cementing inlays,onlays, crowns, bridgesand veneers using acomposite resin cement | ||
| Mechanismof Action | Bond restorations to teeth. | Bond restorations to teeth. | Bond restorations to teeth. |
| Composition | Bisphenol AGlycidylMethacrylate UrethaneDimethacrylate Triethylene GlycolDimethacrylate 2-Hydroxethylmethylacrylate Ethanol DLCamphorquinone Ethyl-4 Di methylamino benzoate Butylated hydroxytoluene (BHT) 2-dimethyl aminoethylMethyacrylate DM water 10-MethacryloxydecylDihydogenPhosphate | Bisphenoldiglycidylmethacrylate EthoxylatedBisphenol ADimethacrylate UrethaneDimethacrylate Triethylene GlycolDimethacrylate 2-Hydroxethylmethylacrylate camphoroquinone Ethyl-4 Di methylamino benzoate Ethanol Acetone | Bisphenol AGlycidylMethacrylate 10-MethacryloxydecylDihydogenPhosphate 2-Hydroxethylmethylacrylate Hydrophobicaliphaticdimethacrylate Dimethacrylatemonomer dl-Camphorquinone Microfillers Initiators Accelerators |
| ApplicableStandards | ISO 29022 - Dentistry -Adhesive - Notched-edgeshear bond strength test | ISO 29022 - Dentistry -Adhesive - Notched-edgeshear bond strength test | ISO 29022 - Dentistry -Adhesive - Notched-edgeshear bond strength test |
| Complies with ISO 29022 | Complies with ISO 29022 | Complies with ISO 29022 | |
| Shear BondStrength | 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 510ksummary, packageinformation says 3 years | Not identified in 510ksummary, packageinformation says 2 years |
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| Renew Universal | Prolink K110403 fromSilmetAdditional PredicateDevice | Clearfil SE Bond 2 K131432from KurarayPredicate Device | |
|---|---|---|---|
| Product Code | KLE | KLE | KLE |
| Indications for Use | Renew Universal isindicated for directbonding of light-curedcomposites, andcompomers to toothstructure, bonding of dual-cured core build upcomposites to toothstructure as long as thesematerials are light-cured,intraoral repair ofcomposite, metal-basedand zirconia /alumina-based restorations,intraoral repair of ceramicrestorations incombination with a silanecoupling agent, treatmentof hypersensitive teeth,and cavity sealing as apretreatment for indirectrestorations. | Direct Composite orCompomer restorationsAdhesive cementationComposite repair | [1] Direct restorationsusing light-curedcomposite resin[2] Cavity sealing as apretreatment for indirectrestorations[3] Treatment of exposedroot surfaces[4] Treatment ofhypersensitive teeth[5] Intraoral repairs offractured restorations[6] Post cementation usinga dual- or self-curedcomposite resin[7] Core build-ups using alight-, dual- or self-curedcore material[8] Cementing inlays,onlays, crowns, bridgesand veneers using acomposite resin cement |
| Mechanism of Action | Bond restorations to teeth. | Bond restorations to teeth. | Bond restorations to teeth. |
| Composition | Bisphenol AGlycidylMethacrylate UrethaneDimethacrylate Triethylene GlycolDimethacrylate | Bisphenoldiglycidylmethacrylate EthoxylatedBisphenol ADimethacrylate UrethaneDimethacrylate | Bisphenol AGlycidylMethacrylate 10-MethacryloxydecylDihydogenPhosphate |
| • 2-Hydroxethylmethylacrylate• Ethanol• DLCamphorquinone• Ethyl-4 Di methylamino benzoate• Butylated hydroxytoluene (BHT)• 2-dimethyl aminoethylMethyacrylate• DM water• 4-2-MethacryloxyethylTrimelltic | • Triethylene GlycolDimethacrylate• 2-Hydroxethylmethylacrylate• camphoroquinone• Ethyl-4 Di methylamino benzoate• EthanolAcetone | • 2-Hydroxethylmethylacrylate• Hydrophobicaliphaticdimethacrylate• Dimethacrylatemonomer• dl-Camphorquinone• Microfillers• Initiators• Accelerators | |
| ApplicableStandards | ISO 29022 - Dentistry -Adhesive - Notched-edgeshear bond strength test | ISO 29022 - Dentistry -Adhesive - Notched-edgeshear bond strength test | ISO 29022 - Dentistry -Adhesive - Notched-edgeshear bond strength test |
| Shear BondStrength | Complies with ISO 2902221 MPa | Complies with ISO 2902214 MPa | Complies with ISO 2902212.45 MPa or 30 MPa |
| Curing Time | Complies with ISO 2902220-30 secs | Complies with ISO 2902220 sec | Complies with ISO 2902210 sec |
| Shelf Life | 2 years | Not identified in 510ksummary, packageinformation says 3 years | Not identified in 510ksummary, packageinformation 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.
§ 872.3200 Resin tooth bonding agent.
(a)
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.(b)
Classification. Class II.