VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH

K092141 · 3M Espe Dental Products · LBH · Mar 10, 2010 · Dental

Device Facts

• Record ID: K092141
• Device Name: VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH
• Applicant: 3M Espe Dental Products
• Product Code: LBH · Dental
• Decision Date: Mar 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Treatment of hypersensitive teeth Use on exposed dentin and root sensitivity 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 and calcium phosphate in a rosin-based preparation. Applied by dental professionals to enamel and dentin surfaces; the varnish forms an insoluble, viscous film that facilitates the occlusion of compromised surfaces, including open dentinal tubules. This occlusion provides relief from tooth surface hypersensitivity. The device is used in a clinical dental setting to treat hypersensitivity and manage post-operative sensitivity under temporary restorations.

Clinical Evidence

Bench testing only. Biocompatibility assessment conducted in accordance with ISO 10993 and ISO 7405 standards.

Technological Characteristics

Rosin-based cavity varnish containing 5% sodium fluoride and tri-calcium phosphate. Formulated as an insoluble, viscous liquid that forms a film on tooth surfaces. Biocompatibility tested per ISO 10993 and ISO 7405.

Indications for Use

Indicated for patients requiring treatment of hypersensitive teeth, exposed dentin, root sensitivity, or protection under temporary restoratives and cements to address post-operative sensitivity.

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

• 3M™ ESPE™ Vanish™ Varnish
• Enamel Pro® Varnish

Submission Summary (Full Text)

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K092141

Image /page/0/Picture/1 description: The image shows the logo for 3M ESPE. The logo is in black and white, with the "3M" part of the logo being larger than the "ESPE" part. The font is sans-serif and bolded.

Vanish™ Varnish, 5% Sodium Fluoride White Varnish Traditional 510(k)

3M CONFIDENTIAL

#### ડ. 510(k) Summary

# MAR 1 0 2010

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

Image /page/0/Picture/8 description: The image shows the logo for 3M ESPE. The logo consists of the text "3M" in a stylized font, followed by the text "ESPE" in a bold, sans-serif font. The text is black and the background is white.

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

| 510(k) Submitter................................ | 3M Company<br>3M ESPE Dental Products<br>3M Center, Bldg. 275-2W-08<br>St. Paul, MN 55144-1000 USA<br>Establishment Registration Number:<br>2110898 |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person................................ | Shari L. Myszka<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Alternate Contact Person................................ | Gretchen E. Keenan<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Summary was Prepared......................... | 5 March 2010 |
| Trade Name................................ | Vanish™ Varnish, 5% Sodium<br>Fluoride White Varnish |
| Common Name(s)................................ | Cavity Varnish |

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3M ESPE

3M CONFIDENTIAL

11

Vanish™ Varnish, 5% Sodium Fluoride White Varnish Traditional 510(k)

Recommended Classification.......... Cavity Varnish (21 CFR 872.3260)

Predicate Devices: 3M™ ESPETM Vanish™ Varnish Enamel Pro® Varnish

## 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 and calcium phosphate in a rosin based preparation. The varnish is an insoluble viscous liquid that forms a film on tooth surfaces.

The chemical composition is identical, with the exception of tri-calcium phosphate (TCP), to predicate fluoride containing rosin based cavity varnish devices that have been in use for decades. More recently, varnishes have incorporated calcium and phosphate. Published literature indicates that the incorporation of calcium based ingredients into oral care products aid in mineral deposition. 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:

- · Treatment of hypersensitive teeth
- · Use on exposed dentin and root sensitivity

· Under temporary restoratives and cements where post-operative sensitivity is of concern

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

# MAR 1 0 2010

Shari L. Myszka, Ph. D. Regulatory Affairs Specialist 3M ESPE Dental Products 3M Center, Building 275-2W-08 St. Paul. Minnesota 55144

Re: K092141

Trade/Device Name: Vanish™ Varnish, 5% Sodium Fluoride White Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: February 17, 2010 Received: February 19, 2010

Dear Dr. Myszka:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

ul, Minnesota S

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## Page 2- Dr. Myszka

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ph for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K092141

Image /page/4/Picture/1 description: The image shows the logo for 3M ESPE. The logo is in black and white. The text is simple and easy to read.

Vanish™ Varnish, 5% Sodium Fluoride White Varnish Traditional 510(k)

3M CONFIDENTIAL

### Indications for Use Statement 4.

## Indications for Use

510(k) Number (if known):

Device Name: Vanish™ Varnish, 5% Sodium Fluoride White 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 X (Part 21 CFR 801 Subpart D)

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

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

RSBetz DDS for Dr. KPV Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
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| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
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| 510(k) Number: | K092141 |

March 5, 2010

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