S&C-SELF ETCH PR-BOND by S & C POLYMER GMBH

This document is a 510(k) clearance letter for a dental adhesive, not a study report. Therefore, it does not contain specific acceptance criteria or reported device performance metrics in the format of a table. The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices. This implies that its performance, as demonstrated by the manufacturer, met the FDA's criteria for equivalence based on existing devices.

2. Sample Size for Test Set and Data Provenance:

Not applicable. This is a 510(k) clearance letter, not a clinical study report. Information regarding specific test set sample sizes or data provenance (country of origin, retrospective/prospective) for equivalence testing would have been part of the manufacturer's submission to the FDA, but is not detailed in this public document.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This document does not describe the establishment of a ground truth with experts. The "substantial equivalence" determination relies on comparisons to predicate devices, where performance data would have been submitted by the manufacturer.

4. Adjudication Method for Test Set:

Not applicable. This document is not a study report and does not describe an adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This document is a regulatory approval letter for a dental adhesive. MRMC studies are typically used for diagnostic devices involving human interpretation of medical images.

6. Standalone Performance Study:

Not explicitly detailed. The 510(k) process involves the manufacturer providing data to demonstrate the device's safety and effectiveness (or substantial equivalence). While this would include in-vitro and potentially in-vivo testing, a "standalone algorithm only" performance study is not relevant for a physical dental adhesive product. The device itself is the "standalone" entity.

7. Type of Ground Truth Used:

Not directly specified in this document. For a dental adhesive, the "ground truth" used for demonstrating substantial equivalence would likely involve a combination of:

Physical and Mechanical Property Testing: Adhesion strength, bond durability, wear resistance, etc., measured according to established standards.
Biocompatibility Testing: To ensure the material is not harmful to tissues.
Clinical Performance Data: If available and necessary, from studies demonstrating comparable clinical outcomes to predicate devices.
This document does not detail how the ground truth for these tests was established beyond the general presumption of adherence to relevant standards.

8. Sample Size for the Training Set:

Not applicable. This is a physical product (dental adhesive), not an AI or algorithm-based device that typically requires a "training set" in the computational sense. The product's formulation and manufacturing process would be developed and refined through R&D, but this isn't analogous to an algorithm's training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the reasons stated in point 8.

Summary

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 2 2004

Dr. Christian Boettcher Regulatory Compliance Officer S&C Polymer GmbH Robert-Bosch-Straße 5 D-25335 Elmshorn GERMANY

Re: K042614

Trade/Device Name: S&C Self Etch Primebond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 22, 2004 Received: September 24, 2004

Dear Dr. Boettcher:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Dr. Christian Boettcher

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Signature

Chiu S. Lin, PhD 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

510(k) Number (if known): K042614

Device Name: S&C Self Etch Primebond Indications for Use:

S&C Self Etch Primebond is intended for bonding composites, compomers, and resin modified glass ionomer cements to enamel and dentin.

Prescription Use X (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Russe

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: _

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Regulation Number and Section

§ 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.