(60 days)
No
The device description and intended use are focused on the chemical composition and physical properties of dental bonding agents, with no mention of AI or ML.
No.
The devices are bonding agents used to attach restorations to teeth, not to treat a disease or condition. They facilitate a procedure rather than provide therapy.
No
The device description clearly states that these are "Tooth Bonding Agents" used to "attach different types of restorations to teeth." Their intended use is for bonding, repair, and cementation of dental restorations, which are therapeutic functions, not diagnostic ones.
No
The device description clearly describes chemical bonding agents, which are physical substances, not software.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device descriptions clearly state that these products are used to bond materials to tooth structure, which is part of the human body, but they are not used to analyze or test specimens from the body for diagnostic purposes.
- The function is mechanical/adhesive. The primary function of these devices is to create a bond between dental restorative materials and the tooth. This is a physical process, not a diagnostic one.
- The performance metrics are related to bonding strength and curing time. These metrics are relevant to the physical properties and effectiveness of the adhesive, not to the diagnosis of a disease or condition.
Therefore, these devices fall under the category of dental restorative materials or adhesives, not In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KLE
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth structure
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Shear Bond Strength:
Fusion Bond 5: Complies with ISO 29022 10 MPA
Fusion Bond 7: Complies with ISO 29022 25 MPA
Fusion Bond DC: Complies with ISO 29022 19 MPa
Renew MDP: Complies with ISO 29022 21 MPa
Renew Universal: Complies with ISO 29022 21 MPa
Curing Time:
Fusion Bond 5: Complies with ISO 29022 20-30 sec
Fusion Bond 7: Complies with ISO 29022 20-30 sec
Fusion Bond DC: Complies with ISO 29022 20-30 secs
Renew MDP: Complies with ISO 29022 20-30 secs
Renew Universal: Complies with ISO 29022 20-30 secs
Shelf Life:
Fusion Bond 5: 3 years
Fusion Bond 7: 3 years
Fusion Bond DC: 2 years
Renew MDP: 2 years
Renew Universal: 2 years
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K133318, K070538, K212457, K060684, K210804, K992985
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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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.