FLUORIDE VARNISH

K031932 · Dentsply Intl. · LBH · Sep 15, 2003 · Dental

Device Facts

• Record ID: K031932
• Device Name: FLUORIDE VARNISH
• Applicant: Dentsply Intl.
• Product Code: LBH · Dental
• Decision Date: Sep 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for: 1) treatment of hypersensitive teeth: 2) sealing the dentinal tubules for cavity preparations or on sensitive root surfaces; and 3) a cavity liner.

Device Story

Fluoride Varnish is a dental material applied to prepared tooth surfaces prior to restorative material placement. It functions as a cavity liner and sealant for dentinal tubules, while providing releasable fluoride. The device is supplied in unit dose vials with applicator brushes, with each vial containing sufficient material to treat 4-8 teeth. It is intended for professional use by dental clinicians in a clinical setting to prevent restorative materials from penetrating dentinal tissue and to treat tooth hypersensitivity.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed, including evaluations for cytotoxicity, acute oral toxicity, irritation, and sensitization. No clinical trial data was required or provided.

Technological Characteristics

Fluoride-releasing varnish supplied in unit dose vials with applicator brushes. Components consist of materials previously used in legally marketed dental devices. Biocompatibility confirmed via standard testing protocols.

Indications for Use

Indicated for the treatment of hypersensitive teeth, sealing of dentinal tubules for cavity preparations or on sensitive root surfaces, and use as a cavity liner.

Regulatory Classification

Identification

Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.

Special Controls

*Classification.* Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Predicate Devices

• Duraphat Fluoride Varnish (K945794)
• Duragard Fluoride Varnish (K002581)

Submission Summary (Full Text)

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SEP 1 5 2003

## 510(k) SUMMARY

DENTSPLY

## NAME & ADDRESS:

NTSPLY Internationa 70 West College Avenue .O. Box 872 York, PA 17405-0872 717| 845-7511 ww.dentsplv.com

Ko 31932

P. J. Lehn Telefax [phone]

| CONTACT: | P. Jeffery Lehn | |
|----------------------------|---------------------------|----------|
| DATE PREPARED: | June 19, 2003 | |
| TRADE OR PROPRIETARY NAME: | FLUORIDE VARNISH | |
| CLASSIFICATION NAME: | Cavity Varnish | 872.3260 |
| PRE DICATE DEVICES: | Duraphat Fluoride Varnish | K945794 |
| | Duragard Fluoride Varnish | K002581 |

DEVICE DESCRIPTION: FLUORIDE VARNISH coats a prepared tooth surface prior to placement of any restorative materials to prevent any of the restorative materials from pene rating into the dentinal tissue. FLUORIDE VARNISH contains releasable fluoride.

FLUORIDE VARNISH will be offered in unit dose vials with applicator brushes. Each vial contins material to treat 4-8 teeth, depending on their size.

INTENDED USE: Intended for: 1) treatment of hypersensitive teeth: 2) sealing the dentinal tubu es for cavity preparations or on sensitive root surfaces; and 3) a cavity liner.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in FLUORIDE VAF NISH have been used in legally marketed devices or were found safe for dental use.

FLUORIDE VARNISH has been evaluated and passed biocompatibility testing for cytotoxicity, acut : oral toxicity, irritation, and sensitization.

We selieve that the prior use of the components of FLUORIDE VARNISH in legally marketed predicate devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of FLUORIDE VARNISH for the indicated uses.

11 - 12.04

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Public Health Service

SEP 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

Re: K031932

Trade/Device Name: Fluoride Varnish Regulation Number: 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: June 19, 2003 . Received: June 23, 2003

Dear Mr. Lehn:

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 - Mr. Lehn

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 (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) 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Susan Runner, DDS, MA Interim 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 STATEMENT

(As Required by 21 CFR 807.87(e)

510(K) Number (if known): 4503 (932

FLUORIDE VARNISH Device Name:

Indications for Use:

- Treatment of hypersensitive teeth e
- () Sealing of dentinal tubules for cavity preparations or on sensitive root surfaces
- Cavity liner t)

Kein Mulay for MSA

on of Anesthesiology. General Hospital, Infection Control, Dental Devices

510(k) Number:_

(PI.EASE: DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

I rescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)