ETCHING GEL by SILICON-UND COMPOSITE SPEZIALITATEN GMBH

This document is a 510(k) premarket notification for a dental etching gel, not a study report detailing performance criteria and results of a device. Therefore, most of the requested information cannot be extracted directly from the provided text.

Based on the information provided:

A table of acceptance criteria and the reported device performance: Not available. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance criteria and results from a clinical or analytical study.
Sample size used for the test set and the data provenance: Not applicable/Not available. This document does not describe a clinical or analytical study with a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not available.
Adjudication method for the test set: Not applicable/Not available.
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: Not applicable. This device is a chemical product (etching gel), not an AI-assisted diagnostic or therapeutic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an etching gel.
The type of ground truth used: Not applicable/Not available for a clinical study. For substantial equivalence, the "ground truth" is that the new device has "substantially similar" chemical composition, intended use, performance, indications, labels, and instructions for use to the predicate device.
The sample size for the training set: Not applicable/Not available. This document does not pertain to a machine learning or AI algorithm where a "training set" would be used.
How the ground truth for the training set was established: Not applicable/Not available.

Summary based on the provided text:

The document describes the submission of a 510(k) premarket notification for an "ETCHING GEL" manufactured by S & C Polymer GmbH. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, "ETCH GEL" by HENRY SCHEIN.

The key information regarding "acceptance criteria" and "study" in this context is centered around the concept of substantial equivalence as defined by the FDA for medical devices.

Acceptance Criteria (Implicit for 510(k) clearance): The "acceptance criteria" for 510(k) clearance in this case is that the device, ETCHING GEL, is "substantially equivalent" to a predicate device ("ETCH GEL" by HENRY SCHEIN). This means it must have:
- The same intended use.
- The same technological characteristics (or if different, that the differences do not raise new questions of safety and effectiveness).
- Similar performance, indications, proposed labels, and instructions for use.
- A chemical composition commonly found in current dental materials.
Study That Proves the Device Meets Acceptance Criteria: The "study" here is the 510(k) premarket notification process itself, which involves providing documentation to the FDA to demonstrate substantial equivalence. The document states:
- "The chemical composition and use of ETCHING GEL is substantially equivalent to 'ETCH GEL', a product manufactured and marketed as an own brand by HENRY SCHEIN."
- "S & C Polymer GmbH's and HENRY SCHEIN's intended use, performance, indications, proposed labels and instructions for use (see attached) are substantially similar to the predicted device (see attached)."

Therefore, the "proof" that the device meets the "acceptance criteria" (of substantial equivalence) is the assertion and supporting documentation within the 510(k) application, which compares the new device to the predicate device across various attributes. This is not a formal clinical trial or performance study as might be conducted for novel, higher-risk devices or software.

Summary

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S & C Polymer

JUL - 9 1999

10. 510(k) Summary or Statement

K99450

SUMMARY

Gentleman:

This submission is pursuent to paragraph 510(k) of the Federal Drug and Cosmetic Act of May. 1976 (as amended) (Title 21 USC). All informations contained herein are to be considered and treated as CONFIDENTIAL COMMERCIAL INFORMATION.

It is the intention of S & C Polymer GmbH to manufacture the ETCHING GEL cited above which can be used as an etching material for dental use.

S & C Polymer spezializes in manufacturing, distributing and marketing numerous dental materials and related items worldwide.

It is S & C Polymer GmbH's intention to manufacture the cited product herein at its facility located at Robert-Bosch-Straße 5, D-25335 Elmshorn (formerly Offenauer Weg 19, D-25335 Bokholt-Hanredder), Germany, employing Good Manufacturing Practices (GMP`s) pursuant and according to Title 21 CFR. S & C Polymer GmbH is certified to DIN EN ISO 9001 / DIN EN 46001 and Medical Device Directive 93/42/EEC, annex II.

The above cited product may be offered and marketed in the United States by Pharmex and Henry Schein, in which case S & C Polymer will maintain control and govern the production and primary packaging. Pharmex and Henry Schein will maintain the claims, labels, instructions and indications by themselves which are consistent with this submission and final FDA 510(k) clearance to market by Pharmex and Henry Schein.

The cited ETCHING GEL S & C Polymer GmbH manufactures for Pharmex and Henry Schein contains Pharmex and Henry Schein and chemistry commonly found in current dental materials.

The purpose of this material for use by the dentist is to clinically reline dentures. The material is in general placed against an applied adhesive system on the protheses.

The chemical composition and use of ETCHING GEL is substantially equivalent to "ETCH GEL", a product manufactured and marketed as an own brand by HENRY SCHEIN. S & C Polymer GmbH's and HENRY SCHEIN's intended use, performance, indications, proposed labels and instructions for use (see attached) are substantially similar to the predicted device (see attached).

Respectfully submitted

Jürgen Engelbrecht, Ph. D.
Regulatory Compliance Officer

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with lines suggesting movement or progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 1999

Jurgen Engelbrecht, Ph.D. President Regulatory Compliance Officer Silicon-und Composite Spezialitaten GmbH Robert-Bosch-Strasse 5 Elmshorn GERMANY

Re : K991450 ETCHING GEL Trade Name: Regulatory Class: II Product Code: EBF Dated: April 1, 1999 Received: April 26, 1999

Dear Dr. Engelbrecht:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Engelbrecht

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):	K991450	Page 1 of 1
Device Name:	ETCHING GEL
Indications For Use:	For etching dentin and enamel.

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

Concurrence of CDRH, Office of Device Evaluation (QDE)

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use (Optional Forma
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(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number

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Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.