ONE COAT SE BOND

K033760 · Coltene/Whaledent, Inc. · KLE · Jan 23, 2004 · Dental

Device Facts

• Record ID: K033760
• Device Name: ONE COAT SE BOND
• Applicant: Coltene/Whaledent, Inc.
• Product Code: KLE · Dental
• Decision Date: Jan 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

One Coat SE Bond, a self etching dental adhesive, is indicated for the following: - The bonding of indirect restorations (inlays, onlays, veneers, when used with . lightcure or dual cure luting cements) to tooth structure. - The bonding of direct fillings of composite or compomer. . - The bonding of composite to amalgam. . - The repairing of metal/ceramic, ceramic or composite restorations. . - The sealing of sensitive teeth. .

Device Story

One Coat SE Bond is a self-etching dental adhesive system. It is applied by a dental professional to tooth structure or restorative materials to facilitate bonding. The device functions as a chemical bonding agent for direct and indirect restorations, including composite, compomer, and amalgam. It is used in clinical dental settings to improve restoration retention and seal sensitive tooth surfaces. The adhesive is applied directly to the prepared site, providing a chemical interface between the tooth and the restorative material.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Self-etching dental adhesive system; chemical bonding agent; liquid form factor; intended for professional dental use.

Indications for Use

Indicated for dental patients requiring bonding of indirect restorations (inlays, onlays, veneers) with light/dual cure cements, direct composite/compomer fillings, composite-to-amalgam bonding, repair of metal/ceramic/composite restorations, and sealing of sensitive teeth.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2004

Coltene/Whaledent Incorporated C/O Mr. Henry J. Vogelstein Consultant 1349 Lexington Avenue New York, New York 10128

Re: K033760

Trade/Device Name: One Coat SE Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE Dated: November 28, 2003 Received: December 02, 2003

Dear Mr. Vogelstein:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have revewed your Section 770(x) premained is substantially equivalent (for the indications for referenced above and have decemined are ed predicate devices marketed in interstate since show use stated in the encreating thanksettle Medical Device Amendments, or to devices that prior to May 26, 1970, the chacinent and of the Federal Food, Drug, and Cosmetic have been reclassified in accordance with are proval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the device, sabject to the general registration, listing of devices, good controls provisions of the fiel measure prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) microsoft regulations affecting your device can be
may be subject to such additional controls. Existing major regulations of DA may may be subject to such additional controls. 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. Henry J. Vogelstein

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); an the rece of CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) 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) This lotter will and my Jowe FDA finding of substantial equivalence of your device to a legally premated notificated evice 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 If you desire specific at not is 101 ) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, and wate 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chas.

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): K033760

## Device Name: One Coat SE Bond

### Indications for Use:

One Coat SE Bond, a self etching dental adhesive, is indicated for the following:

- The bonding of indirect restorations (inlays, onlays, veneers, when used with . lightcure or dual cure luting cements) to tooth structure.
- The bonding of direct fillings of composite or compomer. .
- The bonding of composite to amalgam. .
- The repairing of metal/ceramic, ceramic or composite restorations. .
- The sealing of sensitive teeth. .

Prescription Use
(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)

signature

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K033760
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