ETCHING GEL

K991450 · Silicon-Und Composite Spezialitaten GmbH · EBF · Jul 9, 1999 · Dental

Device Facts

• Record ID: K991450
• Device Name: ETCHING GEL
• Applicant: Silicon-Und Composite Spezialitaten GmbH
• Product Code: EBF · Dental
• Decision Date: Jul 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

For etching dentin and enamel.

Device Story

Etching gel used by dentists for dental procedures; applied to dentin and enamel surfaces to prepare for bonding or restorative materials. Device functions as a chemical etchant; composition consistent with existing dental materials. Used in clinical dental settings by licensed professionals. Output is a prepared tooth surface; facilitates adhesion of restorative materials to tooth structure, improving clinical outcomes for dental restorations.

Clinical Evidence

No clinical data provided; substantial equivalence is based on chemical composition and intended use similarity to the predicate device.

Technological Characteristics

Chemical etching gel for dental use. Composition consists of chemistry commonly found in current dental materials. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for etching dentin and enamel in dental procedures.

Regulatory Classification

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.

Predicate Devices

• ETCH GEL (Henry Schein)

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 |
|---------------------------------------|----|--------------------------------------|
|---------------------------------------|----|--------------------------------------|

(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number

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