Who is the manufacturer of Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal?

Prevest Denpro Limited filed the 510(k) submission for Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal (K231696).

What is the FDA product code for Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal?

KLE. It is classified under 21 CFR 872.3200 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal?

Prolink and Prolink SE (K110403); Clearfil Photo Bond (K943165); Clearfil SE Bond 2 (K131432).

Who can help prepare an FDA 510(k) submission like Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal

K231696 · Prevest Denpro Limited · KLE · Aug 11, 2023 · Dental

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
Attributes	Therapeutic

Intended 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

Prolink and Prolink SE (K110403)
Clearfil Photo Bond (K943165)
Clearfil SE Bond 2 (K131432)

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)

Related Devices

K011908 — OPTIBOND SOLO PLUS 3 · Kerr Dental Materials Center · Sep 6, 2001
K260682 — Bond-PR Universal Adhesive · Premier Dental Products Company · Mar 3, 2026
K132450 — CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND · Kuraray Noritake Dental, Inc. · Nov 1, 2013
K111980 — CLEARFIL TRI-S BOND PLUS · Kuraray America, Inc. · Oct 14, 2011
K120767 — ES BOND · Spident Co., Ltd. · May 24, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ #### 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 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. {4}------------------------------------------------ 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 compomer restorations, adhesive cementation, and composite repair. | | Fusion Bond 7 | 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 | 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 | 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 | Renew Universal is indicated for direct bonding of light-cured composites, and 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. | ## 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. {5}------------------------------------------------ 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 Predicate Device | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | KLE | KLE | | Indications for Use | Fusion Bond 5 is indicated for direct composite or compomer restorations, adhesive cementation, and composite repair. | Direct Composite or Compomer restorations Adhesive cementation Composite repair | | Mechanism of Action | Bond restorations to teeth. | Bond restorations to teeth. | | Applicable Standards | ISO 29022 - Dentistry - Adhesive – Notched-edge shear bond strength test | ISO 29022 - Dentistry - Adhesive – Notched-edge shear bond strength test | | Compositio n | Bisphenol A Glycidyl MethacrylateEthoxylated Bisphenol A DimethacrylateUrethane DimethacrylateTriethylene Glycol Dimethacrylate2-Hydroxethylmethyl acrylateCamphorquinoneEthyl-4 Di methyl amino benzoateTertiary butanol | Bisphenol diglycidyl methacrylateEthoxylated Bisphenol A DimethacrylateUrethane DimethacrylateTriethylene Glycol Dimethacrylate2-Hydroxethylmethyl acrylatecamphoroquinoneEthyl-4 Di methyl amino benzoateEthanol | ### Resin Tooth Bonding Agents from Prevest Denpro {6}------------------------------------------------ | | Butylated hydroxy toluene (BHT) 2-dimethyl amino ethyl Methyacrylate | Acetone | |------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------| | Shear Bond Strength | Complies with ISO 29022 10 MPA | Complies with ISO 29022 14 MPa | | Curing Time | Complies with ISO 29022 20-30 sec | Complies with ISO 29022 20 sec | | Shelf Life | 3 years | Not identified in 510k summary, package information says 3 years | | | Fusion Bond 7 | Prolink SE K110403 from Silmet Predicate Device | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | KLE | KLE | | Indications for Use | 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. | Bonding of composites to tooth structure Core Build up Adhesive cementation of crown & bridges, including inlays and onlays | | Mechanism of Action | Bond restorations to teeth. | Bond restorations to teeth. | | Composition | Bisphenol A Glycidyl Methacrylate Ethoxylated Bisphenol A Dimethacrylate Urethane Dimethacrylate Triethylene Glycol Dimethacrylate Hydroxethylmethyl Phosphate Camphorquinone Ethyl-4 Di methyl amino benzoate Tertiary butanol Butylated hydroxy toluene (BHT) 2-dimethyl amino ethyl Methyacrylate | Bisphenol diglycidyl methacrylate Ethoxylated Bisphenol A Dimethacrylate Urethane Dimethacrylate Triethylene Glycol Dimethacrylate 2-Hydroxethylmethyl acrylate camphoroquinone Ethyl-4 Di methyl amino benzoate Ethanol Acetone | | Applicable Standards | ISO 29022 - Dentistry - Adhesive – Notched-edge shear bond strength test | ISO 29022 - Dentistry - Adhesive – Notched-edge shear bond strength test | {7}------------------------------------------------ | Shear Bond Strength | Complies with ISO 29022 25 MPA | Complies with ISO 29022 29MPa | |------------------------|--------------------------------------|---------------------------------------------------------------------| | Curing Time | Complies with ISO 29022 20-30 sec | Complies with ISO 29022 20 sec | | Shelf Life | 3 years | Not identified in 510k summary, package information says 3 years | | | Fusion Bond DC | Clearfil Photo Bond K943165 from Kuraray Additional Predicate Device | Prolink K110403 from Silmet Predicate Device | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Product Code | KLE | KLE | KLE | | Indications for Use | 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. | No 510k database file | Direct Composite or Compomer restorations Adhesive cementation Composite repair | | Mechanism of Action | Bond restorations to teeth. | Bond restorations to teeth. | Bond restorations to teeth. | | Composition | Fusion Bond DC Bonding 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 | {8}------------------------------------------------ | | Butylated hydroxy toluene (BHT) Fusion Bond DC Activator Bisphenol A Glycidyl Methacrylate Ethoxylated Bisphenol A Dimethacrylate Urethane Dimethacrylate Triethylene Glycol Benzyl Peroxide Tertiary butanol Butylated hydroxy toluene (BHT) | 2-Hydroxethylmethyl acrylate Hydrophobic Dimethacrylate Benzyl Peroxide DL-Camphorquinone | | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | Applicable Standards | ISO 29022 - Dentistry - Adhesive - Notched- edge shear bond strength test | ISO 29022 - Dentistry - Adhesive - Notched-edge shear bond strength test | ISO 29022 - Dentistry - Adhesive - Notched-edge shear bond strength test | | Shear Bond Strength | Complies with ISO 29022 19 MPa | Complies with ISO 29022 15.9 MPa | Complies with ISO 29022 14 MPa | | Curing Time | Complies with ISO 29022 20-30 secs | Complies with ISO 29022 10 sec | Complies with ISO 29022 20 sec | | Shelf Life | 2 years | Unknown | Not identified in 510k summary, package information says 3 years | | | Renew MDP | Prolink K110403 from Silmet Additional Predicate Device | Clearfil SE Bond 2 K131432 from Kuraray Predicate Device | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | KLE | KLE | KLE | | Indications for Use | Renew MDP is indicated for bonding of dual cure, light cure or self cure composite or compomer restorations to tooth | Direct Composite or Compomer restorations Adhesive cementation Composite repair | [1] Direct restorations using light-cured composite resin [2] Cavity sealing as a pretreatment for indirect restorations | | | structure, treatment of hypersensitive teeth, and intraoral repairs of fractured restorations. | | [3] Treatment of exposed root surfaces [4] Treatment of hypersensitive teeth [5] Intraoral repairs of fractured restorations [6] Post cementation using a dual- or self-cured composite resin [7] Core build-ups using a light-, dual- or self-cured core material [8] Cementing inlays, onlays, crowns, bridges and veneers using a composite resin cement | | Mechanism of Action | Bond restorations to teeth. | Bond restorations to teeth. | Bond restorations to teeth. | | Composition | Bisphenol A Glycidyl Methacrylate Urethane Dimethacrylate Triethylene Glycol Dimethacrylate 2- Hydroxethylmethyl acrylate Ethanol DL Camphorquinone Ethyl-4 Di methyl amino benzoate Butylated hydroxy toluene (BHT) 2-dimethyl amino ethyl Methyacrylate DM water 10- Methacryloxydecyl Dihydogen Phosphate | Bisphenol diglycidyl methacrylate Ethoxylated Bisphenol A Dimethacrylate Urethane Dimethacrylate Triethylene Glycol Dimethacrylate 2- Hydroxethylmethyl acrylate camphoroquinone Ethyl-4 Di methyl amino benzoate Ethanol Acetone | Bisphenol A Glycidyl Methacrylate 10- Methacryloxydecyl Dihydogen Phosphate 2- Hydroxethylmethyl acrylate Hydrophobic aliphatic dimethacrylate Dimethacrylate monomer dl- Camphorquinone Microfillers Initiators Accelerators | | Applicable Standards | ISO 29022 - Dentistry - Adhesive - Notched-edge shear bond strength test | ISO 29022 - Dentistry - Adhesive - Notched-edge shear bond strength test | ISO 29022 - Dentistry - Adhesive - Notched-edge shear bond strength test | | | Complies with ISO 29022 | Complies with ISO 29022 | Complies with ISO 29022 | | Shear Bond 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 summary, package information says 3 years | Not identified in 510k summary, package information says 2 years | {9}------------------------------------------------ {10}------------------------------------------------ | | Renew Universal | Prolink K110403 from Silmet Additional Predicate Device | Clearfil SE Bond 2 K131432 from Kuraray Predicate Device | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | KLE | KLE | KLE | | Indications for Use | Renew Universal is indicated for direct bonding of light-cured composites, and 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. | Direct Composite or Compomer restorations Adhesive cementation Composite repair | [1] Direct restorations using light-cured composite resin [2] Cavity sealing as a pretreatment for indirect restorations [3] Treatment of exposed root surfaces [4] Treatment of hypersensitive teeth [5] Intraoral repairs of fractured restorations [6] Post cementation using a dual- or self-cured composite resin [7] Core build-ups using a light-, dual- or self-cured core material [8] Cementing inlays, onlays, crowns, bridges and veneers using a composite resin cement | | Mechanism of Action | Bond restorations to teeth. | Bond restorations to teeth. | Bond restorations to teeth. | | Composition | Bisphenol A Glycidyl Methacrylate Urethane Dimethacrylate Triethylene Glycol Dimethacrylate | Bisphenol diglycidyl methacrylate Ethoxylated Bisphenol A Dimethacrylate Urethane Dimethacrylate | Bisphenol A Glycidyl Methacrylate 10- Methacryloxydecyl Dihydogen Phosphate | | | | | | | | • 2- Hydroxethylmethyl acrylate • Ethanol • DL Camphorquinone • Ethyl-4 Di methyl amino benzoate • Butylated hydroxy toluene (BHT) • 2-dimethyl amino ethyl Methyacrylate • DM water • 4-2- Methacryloxyethyl Trimelltic | • Triethylene Glycol Dimethacrylate • 2- Hydroxethylmethyl acrylate • camphoroquinone • Ethyl-4 Di methyl amino benzoate • Ethanol Acetone | • 2- Hydroxethylmethyl acrylate • Hydrophobic aliphatic dimethacrylate • Dimethacrylate monomer • dl- Camphorquinone • Microfillers • Initiators • Accelerators | | Applicable Standards | ISO 29022 - Dentistry - Adhesive - Notched-edge shear bond strength test | ISO 29022 - Dentistry - Adhesive - Notched-edge shear bond strength test | ISO 29022 - Dentistry - Adhesive - Notched-edge shear bond strength test | | Shear Bond Strength | Complies with ISO 29022 21 MPa | Complies with ISO 29022 14 MPa | Complies with ISO 29022 12.45 MPa or 30 MPa | | Curing Time | Complies with ISO 29022 20-30 secs | Complies with ISO 29022 20 sec | Complies with ISO 29022 10 sec | | Shelf Life | 2 years | Not identified in 510k summary, package information says 3 years | Not identified in 510k summary, package information says 2 years | {11}------------------------------------------------ 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.