VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247

K090519 · 3M Company · LBH · Apr 15, 2009 · Dental

Device Facts

• Record ID: K090519
• Device Name: VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
• Applicant: 3M Company
• Product Code: LBH · Dental
• Decision Date: Apr 15, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vanish Varnish is for use on sensitive teeth, over exposed dentin and root surface sensitivity and under temporary restoratives and cements where post-operative sensitivity is of concern.

Device Story

Vanish Varnish is a topically applied, flavored cavity varnish containing 5% sodium fluoride in a rosin-based preparation. It is applied by a dental professional to enamel and dentin surfaces. The varnish acts as an insoluble, viscous liquid that forms a film upon application, facilitating the occlusion of compromised tooth surfaces, including open dentinal tubules. This mechanism provides relief from tooth surface hypersensitivity. The device is supplied in a dispensing system designed for the simultaneous dispensing of components to ensure a consistent mix.

Clinical Evidence

No clinical data provided. Safety and equivalence were established through biocompatibility testing per ISO 10993 and ISO 7405, and comparison of chemical composition and physical properties to predicate devices.

Technological Characteristics

Topically applied, flavored cavity varnish. Composition: 5% sodium fluoride in a rosin-based preparation. Physical state: Insoluble viscous liquid. Biocompatibility testing performed per ISO 10993 and ISO 7405.

Indications for Use

Indicated for patients with sensitive teeth, exposed dentin, or root surface sensitivity, and for use under temporary restoratives or cements to address post-operative sensitivity concerns.

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 DFV Varnish (K982915)
• Universal Cavity Varnish (K802926)
• DuraShield Plus (K082198)

Submission Summary (Full Text)

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3M ESPE Dental Products 3M Center St. Paul, MN 55144-1000 651 733 1110

090519

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APR 1 5 2009

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### Submitter

Company: Street: ZIP-Code, City: Country: Establishment Registration Number: Official Correspondent:

Phone: Fax: E-mail: Date:

Name of Device

Proprietary Name: Classification Name 3M ESPE Dental Products 3M Center Bldg 260-2A-17 St. Paul, Mn. 55144 USA 2110898 Karen O'Mallev Sr. Regulatory Specialist 651 736-7326 651 737-6049 [e-mail] February 20, 2009

Vanish Varnish Cavity Varnish 21 C.F.R. §872.3260 as a Class II device. Cavity Varnish

Common Name:

### Predicate Devices

| Device | 510(k) |
|--------------------------|---------|
| Sci-Pharm DFV Varnish | K982915 |
| Universal Cavity Varnish | K802926 |
| DuraShield Plus | K082198 |

### Description and Technology Equivalence

Vanish™ Varnish, 5% Sodium Fluoride Varnish is classified as Cavity Varnish (21 C.F.R§872.3260) because it is a device that provides relief from tooth surface hypersensitivity when applied to enamel and dentin surfaces by forming a film that facilitates occlusion of compromised surfaces including open dentinal tubules.

Vanish Varnish is a topically applied. flavored cavity varnish containing sodium fluoride in a rosin based preparation. The varnish is an insoluble viscous liguid that forms a film on tooth surfaces. This dispensing system provides simultaneous dispensing of each component for a consistent mix.

The chemical composition is identical to predicate fluoride containing rosin based cavity varnish devices that have been in use for decades. The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility assessment conducted based on ISO10993 and ISO 7405.

This product is equivalent to current varnishes in properties. intended use and composition. Results provided in the submission confirm the equivalent to the predicate devices with common indications.

#### Indications for Use:

Vanish Varnish is for use on sensitive teeth, over exposed dentin and root surface sensitivity and under temporary restoratives and cements where post-operative sensitivity is of concern.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen O'Malley, RAC 3M Company Dental Products Division 3M Center, Building 260-2A-17 St. Paul, Minnesota 55144-1000

APR 1 5 2009

Re: K090519

Trade/Device Name: Vanish™M Varnish Regulation Number: 21 CFR 872.3260 Regulatory Class: II Product Code: LBH Dated: March 16, 2009 Received: March 18, 2009

Dear Ms. O'Malley:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2- Ms. O'Malley

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely yours,

Susan Torres

Susan Runner, D.D.S., MA Acting 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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K090519

# Indications for use

# Indications for Use Statement Indications for Use

510(k) Number (if known): K09

Device Name: Vanish™ Varnish

## Indications for Use:

- Treatment of hypersensitive teeth .
- use on exposed dentin and root sensitivity ●
- . under temporary restoratives and cements where post-operative sensitivity is of concern.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Susan Perez

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: Y090059