Bonding adhesive restoration techniques.
Direct filling technique:
· Adhesive bonding of composite materials to natural enamel and dentine (coltene® SYNERGY, coltène® Brilliant Dentin/Enamel/Incisal).
Indirect restorative techniques:
· Adhesive bonding of ceramic and composite patterns with coltene® Duo Cement to natural enamel and dentine.
Adhesive bonding of other dental materials:
· composite materials to pretreated ceramics
· composite material to composite material
· composite material to pretreated metals
· dentine sealing
Sclerotic dentin:
· Use 35 % phosphoric acid for 30 s (e.g. coltene® Etchant Gel S)

Device Description

Coltene® ONE COAT BOND is a light-cured, multipurpose, one-component adhesive agent for adhesive restoration techniques in dentistry. Coltène® ETCHANT 15 is a gel used for etching of dentine and enamel before the application of coltène® ONE COAT BOND.

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding the "One Coat Bond Dentin/Enamel Adhesive System." It does not contain a study description, acceptance criteria, or performance data for the device. Therefore, I cannot generate the requested information based on the provided text.

The letter explicitly states: "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...". This indicates that the device was cleared based on demonstrating substantial equivalence to a legally marketed predicate device, rather than through a a new clinical study with acceptance criteria and performance reporting as you've requested.

The document also includes an "Indications For Use" statement and a "Definition" and "Composition" for the product, but these do not constitute a study or performance data.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 1998

Mr. H.J. Vogelstein Coltene/Whaledent, Incorporated 750 Corporate Drive Nahwah, New Jersey 07430

Re: K974906 One Coat Bond Dentin/Enamel Adhesive System Trade Name: Requlatory Class: II Product Code: KLE Dated: March 12, 1998 March 13, 1998 Received:

Dear Mr. Vogelstein:

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, Druq, and Cosmetic Act (Act). 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 (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. ਉੱ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Vogelstein

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

Timot 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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Page 1 of 1

510(k) Number (if known): K974906

One Coat Bond Dentin/Enamel AdhesiveSystem Device Name: 510(k) Submission Indications For Use

Image /page/2/Picture/3 description: The image shows the logo for "coltène whaledent". The word "coltène" is in a bold, sans-serif font, with a dot over the "e". To the right of the word is a graphic of three diagonal lines. Below "coltène" is the word "whaledent", also in a bold, sans-serif font.

0 Cornarata Dris 10ne: 201-512-8000

Indications

Bonding adhesive restoration techniques.

Direct filling technique:

· Adhesive bonding of composite materials to natural enamel and dentine (coltene® SYNERGY, coltène® Brilliant Dentin/Enamel/Incisal).

Indirect restorative techniques:

· Adhesive bonding of ceramic and composite patterns with coltene® Duo Cement to natural enamel and dentine.

Adhesive bonding of other dental materials:

· composite materials to pretreated ceramics
· composite material to composite material
· composite material to pretreated metals
· dentine sealing

Sclerotic dentin:

· Use 35 % phosphoric acid for 30 s (e.g. coltene® Etchant Gel S)

Contra-Indications

Allergy exist to any of the components of coltène® ONE COAT BOND and coltene® ETCHANT 15. If the site cannot be isolated after enamel etching and during application and curing of coltène® ONE COAT BOND. If oral hygiene is poor.

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

Concu Tence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801. (09)

Over-The-Counter Use No

Definition

Composition

Coltène® ONE COAT BOND contains:

Hydroxyethyl methacrylate HEMA Hydroxypropylmethacrylate Glycerinedimethacrylate Polyalkenoate methacrylized Urethanedimethacrylate Amorphe silicic acid

Coltène® ETCHANT 15 contains:

Water, phosphoric acid 15%, gel former

Susan Runne

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 510(k) Number

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.