(209 days)
ProLink: Direct Composite or Compomer restorations, Adhesive cementation, Composite repair. ProLink SE: Bonding of composites to tooth structure, Core Build up, Adhesive cementation of crown & bridges, including inlays and onlays.
ProLink is a 5th generation dentin/enamel single step bonding agent. The primer and adhesive are combined into a single component for ease of application. ProLink delivers outstanding shear bonding values to dentin, enamel & all popular light, dual or auto-cure composites. ProLink SE is a 7th generation light cured self etching dentin/enamel bonding agent. The etch, primer and adhesive are combined into a single component for ease of application. Separate conditioning (etching) of the enamel and dentine is not required.
The provided text describes the performance characteristics of the ProLink adhesives (ProLink, ProLink SE) and compares them to predicate devices. However, it does not include a table of acceptance criteria with specific numerical targets, nor does it detail a study that proves the device meets specific numerical acceptance criteria. Instead, it focuses on substantial equivalence to predicate devices based on general performance characteristics and physical tests.
Here's a breakdown of the information that is present and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as numerical targets. The document lists general performance characteristics expected from the device: "high bond strength," "a thin film thickness," "shelf stability," and "post placement stability." It does not provide threshold values for these characteristics.
- Reported Device Performance: No specific numerical performance values are reported for ProLink adhesives or the predicate devices. The study performed is described as "bench testing to evaluate the performance of the ProLink adhesives (ProLink, ProLink SE) compared to the following predicate devices." This implies a comparative study, but the results (e.g., specific shear bond strength values) are not included in this summary.
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 mentions "bench testing" but does not specify the sample size used for the test set, the country of origin of the data, or whether it was retrospective or prospective.
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 information is not applicable and hence not provided as the study involves bench testing of material properties, not human interpretation of medical images or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set This information is not applicable and hence not provided as the study involves bench testing of material properties, not human interpretation of medical images or diagnoses.
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 This information is not applicable and hence not provided as the study involves bench testing of material properties, not human interpretation of medical images or diagnoses or AI systems.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done This information is not applicable and hence not provided as the study involves bench testing of material properties, not AI or algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Ground truth is established by the bench test measurements themselves (e.g., shear bond strength, marginal integrity). This is a direct measurement of the material's physical properties.
8. The sample size for the training set This information is not applicable and hence not provided as there is no mention of a "training set" as this is not an AI/machine learning study.
9. How the ground truth for the training set was established This information is not applicable and hence not provided as there is no mention of a "training set" or AI/machine learning.
Summary of the Study Mentioned:
- Study Type: Bench testing.
- Purpose: To evaluate the performance of ProLink adhesives (ProLink, ProLink SE) compared to four predicate devices: Adper Single Bond Plus, iBond Total Etch, G-Bond, and Clearfil Tri-S Bond.
- Properties Evaluated:
- Shear Bond strength to etched enamel and to etched dentin
- Marginal integrity
- Conclusion: The submission concludes that ProLink Adhesives are "safe and effective and substantially equivalent to the predicate devices described herein" based on intended use, indications for use, composition, physical properties, and technological characteristics. The results of the bench testing (e.g., specific bond strength values) are not reported in this summary, only that such tests were conducted for comparison to predicate devices. The basis for equivalence relies on similar technological characteristics (e.g., photoinitiator system, resin matrix, fillers, hybrid zone formation, hydrophilicity) and the assumption that if the technological characteristics are similar and the performance tests were conducted, then the new device performs comparably to the legally marketed predicates.
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KINO3
5. 510(k) Summary
This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of 21 C.F.R. part 872.3690
Date prepared: February 8, 2011
Company
| Name | Silmet Ltd |
|---|---|
| Address | 12 Hassadna St., Industrial Park |
| Or Yehuda 60200. Israel | |
| Telephone | 972 3 5331474 |
| Fax | 972 3 5331581 |
| Contact | Moshe Zalsman |
| moshe@silmet.co.il |
Devices
| Trade Name: | ProLink adhesives (ProLink, ProLink SE) |
|---|---|
| Classification Name: | Resin Tooth Bonding Agent (21 CFR 872.3200) |
| Common Name: | Dental Adhesives |
| Regulatory class: | Class II |
Predicate Devices
| Adper Single Bond Plus | (K962785, 3M Dental Products) |
|---|---|
| iBond Total Etch | (K083652, Heraeus Kulzer, GmbH) |
| G-Bond | (K041471, GC America) |
| Clearfil Tri-S Bond | (K042913, Kuraray Medical Inc.) |
Description
- ProLink is a 50 generation dentin/enamel single step bonding agent. The primer and adhesive are . combined into a single component for ease of application. ProLink delivers outstanding shear bonding values to dentin, enamel & all popular light, dual or auto-cure composites.
- ProLink SE is a 7th generation light cured self etching dentin/enamel bonding agent. The etch, primer . and adhesive are combined into a single component for ease of application. Separate conditioning (etching) of the enamel and dentine is not required.
File No. 102010 Profink/SE 510k ~ FDA
SUMET LTD. 12 Hassaha St. Indostral Park. Or Yehub 60201 html. Tel. +972 3 5331551 e-mail.nifo@silmadema.com www.simulesun.html
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. .
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SILME
Device function, scientific concept, physical and performance characteristics
ProLink adhesives establish a bond to both the filling material and the dental hard tissue, i.e. enamel and dentin.
There has been dramatic progression in the adhesion of dental adhesives and resins to enamel and dentin in the 40 years since Buonocore introduced the technique of etching enamel with phosphoric acid to improve adhesion to enamel.
Device components and technological characteristic
Similar to all other dental adhesives ProLink adhesives typically contain resin monomers, curing initiators, inhibitors or stabilizers, solvents and inorganic filler. The resin matrix functions as a backbone providing structural continuity and thus physical - mechanical properties such as strength.
Function Components Fillers Filler particles modify the viscosity of the adhesive, offer Fumed silica higher elasticity ProLink SE ProLink 3% Weight of filler: 5.5 % 0.4 microns Size of filler: 6 microns Resin components Cross linkers that directly provide mechanical strength to Triethyleneglycol dimethacrylate adhesive system by forming densely cross linked polymers, (TEDGMA) helps prevent substantial water uptake after curing Urethandimethacrylate (UDMA) Its hydrophilicity makes it an excellent adhesion promoting 2-Hydroxyethylmethacrylate (HEMA) monomer Multifunctional dimethacrylates enhance wetting of dentin and thus improves bond strength Photo initiators: set off radical polymerization reaction of monomer Camphoroquinone Ethyl 4-dimethylaminobenzoate Solvents: promote good penetration of monomers in the collagen network of the demineralized dentin Ethanol & Acetone
Table 1. Device Composition
File No 82010 Profilfilow 510k - FDA
1 Buonocore MG. A simple method of increasing the adhesion of acrylic filling materials to enamel surfaces. J Dent Res. 1955;34:849-853.
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Indications for use
| ProLink | ProLink SE |
|---|---|
| Direct Composite or Compomer restorations | Bonding of composites to tooth structure |
| Adhesive cementation | Core Build up |
| Composite repair | Adhesive cementation of crown & bridges, including inlaysand onlays |
Contraindications
Patients with a history of hypersensitivity to methacrylate monomers. Pulp capping
Performance characteristics
In addition to withstanding mechanical forces, and in particular shrinkage stress, the ProLink adhesives feature the following characteristics.
- . high bond strength
- a thin film thickness to ensure easy and complete seating of restorations .
- . shelf stability
- post placement stability. .
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Image /page/3/Picture/0 description: The image shows the word "SILMET" in bold, black letters. To the right of the word is a square that is divided into two sections, one white and one black. The rest of the image is blurry and difficult to make out, but it appears to be more text.
Summary of Physical Tests
This 510(k) submission includes data from bench testing to evaluate the performance of the ProLink adhesives (ProLink, ProLink SE) compared to the following predicate devices:
| Adper Single Bond Plus | (K962785) |
|---|---|
| iBond Total Etch | (K083652) |
| G-Bond | (K041471) |
| Clearfil Tri-S Bond | (K042913) |
Properties evaluated include:
-
- Shear Bond strength to etched enamel and to etched dentin
-
- Marginal integrity
Substantial Equivalence Discussion
The information provided in this 510(k) submission shows that the ProLink adhesives are substantially equivalent to:
| Adper Single Bond Plus | (K962785, 3M Dental Products) |
|---|---|
| iBond Total Etch | (K083652, Heraeus Kulzer, GmbH) |
| G-Bond | (K041471, GC America) |
| Clearfil Tri-S Bond | (K042913, Kuraray Medical Inc.) |
The equivalence is in terms of intended use, indications for use, composition, physical properties and technological characteristics. A comparison of technological characteristics is provided below.
| Table 2: Similarity of Technological properties to predicate devices |
|---|
| ---------------------------------------------------------------------- |
| Technological property | ProLinkAdhesives | AdperSingleBondPlus | iBondTotal Etch | G-Bond | ClearfilTri-SBond |
|---|---|---|---|---|---|
| Camphorquinone/aminephotoinitiator system | X | X | X | X | X |
| Methacrylate-based resin matrix | X | X | X | X | X |
| Silane treated fillers | X | X | X | X | X |
| Forms essential hybrid zone | X | X | X | X | X |
| High Hydrophilicity | X | X | X | X | X |
The prior use of all the components in the legally marketed predicate devices supports our decision that additional testing for bio-compatibility with the final formulation are not necessary.
We believe that the prior use of these components in legally marketed devices and the performance data and results support the safety and effectiveness of ProLink adhesives for the intended use.
Conclusion
In accordance with 21 C.F.R. part 807 and FDA's Guidance for the preparation of Premarket Notifications for Dental Composites" and based on the information provided in this premarket notification, Silmet Ltd. concludes that ProLink Adhesives are safe and effective and substantially equivalent to the predicate devices described herein.
SILMET LTD.
8 February 2011
CEO: Moshe Zalsman
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:
File No. 82010 Profilfiew 510k - FDA
14
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Moshe Zalsman CEO Silmet Limited 12 Hassadna Street Or Yehuda Isreal 60200
SEP - 8 2011
Re: K110403
Trade/Device Name: ProLink Adhesive (ProLink, ProLink SE) Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 4, 2011 Received: September 7, 2011
Dear Mr. Zalsman:
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 ffor 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. 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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Page 2 – Mr. Zalsman
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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- Indications for Use Statement
KI10403 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ProLink adhesives (ProLink, ProLink SE)
| Products | Indications for Use |
|---|---|
| ProLink | Direct Composite or Compomer restorationsAdhesive cementationComposite repair |
| ProLink SE | Bonding of composites to tooth structureCore Build upAdhesive cementation of crown & bridges, includinginlays and onlays |
Prescription Use __ V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of
Susan Ruon
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110403
File No. 82010 Profil/flow 510k - FIDA
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§ 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.