FLUORILAQ

K030488 · Pascal Co., Inc. · LBH · May 2, 2003 · Dental

Device Facts

• Record ID: K030488
• Device Name: FLUORILAQ
• Applicant: Pascal Co., Inc.
• Product Code: LBH · Dental
• Decision Date: May 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive root surfaces.

Device Story

Fluorilaq is a dental cavity varnish applied by dental professionals to sensitive teeth. It functions by sealing dentinal tubules on exposed dentin surfaces and under temporary restorations or cements. The device is used in a clinical dental setting to mitigate post-operative sensitivity and enhance the quality and functionality of dental restorations. It is a resinous material applied topically to the tooth structure.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Resinous dental varnish. Composition is substantially equivalent to existing market-cleared resinous cavity varnishes. No specific ASTM standards or energy sources are cited.

Indications for Use

Indicated for use on sensitive teeth with exposed dentin, including root surfaces, and for application in cavity preparations under temporary restoratives and cements to reduce post-operative sensitivity and improve restoration functionality.

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

• Sci-Pharm DVF Varnish (K982915)
• Duraphat (K945794)
• Duraflor (K961893)

Submission Summary (Full Text)

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K030488

MAY - 2 2003

Image /page/0/Picture/2 description: The image shows the logo for Pascal Company, Inc. The logo features a stylized, abstract shape on the left, followed by the word "Pascal" in a bold, sans-serif font. Underneath "Pascal" is the text "Company, Inc." in a smaller font size.

WATS 800/426-805

## VII. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (AS F:EQUIRED BY SECTION 807.92C)

| Submitted by:<br>- | | | | 1) |
|--------------------|--|--|--|----|
|--------------------|--|--|--|----|

Vincent M. Tentarelli Pascal Company, Inc. 2929 NE Northup Way Bellevue, WA 98004 USA Establishment Registration No.: 3011632 2) Date Prepared: March 1, 2003 3) 4) Device Trade Name: Fluorilaq Fluoride Varnish Device Common Name Dental Varnish 5) Cavity Varnish Device Classification Name: 6) Device Class: Class II 7)

- 8) Substantial equivalence: Fluorilaq is substantially equivalent to the originally classified device described in CFR 872.3260 "Varnish, cavity." It is also substantially equivalent and nearly identical to (for example ) the following products that are currently on the market, having been cleared by 510(k)s:

| 510(k) Number | Name of Device | Company |
|---------------|-----------------------|----------------------------------|
| K982915 | Sci-Pharm DVF Varnish | Scientific Pharmaceuticals, Inc. |
| K945794 | Duraphat | Inpharma |
| K961893 | Duraflor | Pharmascience, Inc. |

- 9) The document, "Guidance on the CDRH Premarket Notification Review Program, June 30, 1986 (K86-3)" was used to determine substantial equivalence:
- Fluorilag has the same intended use, as a varnish on sensitive teeth over a) exposed dentin under temporary restoratives and cements and exposed dentin on roots, as many cleared by the 510(k) process as shown above.

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- b) The technological characteristics for this product are the same as those for the predicate devices and other resinous products currently on the market except for minor variations in the same or similar components.
- Descriptive information provided shows that the materials from which Pascal c) Co., Inc.'s Fluorilaq is made are substantially equivalent to (nearly identical with some) those of similar products, used for identical purposes, currently on the market.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and appear to be connected.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2003

Mr. Vincent M. Tentarelli Ouality Assurance Manager Pascal Company, Incorporated 2929 NE Northup Way Bellevue, Washington 98004

Re: K030488

Trade/Device Name: FLUORILAO Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity varnish Regulatory Class: II Product Code: LBH Dated: February 13, 2003 Received: February 14, 2003

Dear Mr. Tentarelli:

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. Tentarelli

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 vours.

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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K030488

## V. STATIEMENT OF INDICATIONS FOR USE

## INDICATIONS

Int inded for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive roc t surfaces.

Kein Mulry fa MSM

Division Sign-General Hospital, Division of Anesthesiology, Infection Control, Dental D

510(k) Number: K 030488