VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL

K140350 · Preventive Technologies, Inc. · LBH · Dec 12, 2014 · Dental

Device Facts

• Record ID: K140350
• Device Name: VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL
• Applicant: Preventive Technologies, Inc.
• Product Code: LBH · Dental
• Decision Date: Dec 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vella® 5% Sodium Fluoride Varnish with NuFluor® and Xylitol® is a topical fluoride varnish for the treatment of dentin hypersensitivity.

Device Story

Vella 5% Sodium Fluoride Varnish is a topical dental treatment containing NuFluor and Xylitol. Applied by dental professionals to tooth surfaces to treat dentin hypersensitivity. Acts as a fluoride delivery system to occlude dentinal tubules; provides relief from sensitivity. Used in clinical dental settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Topical varnish formulation containing 5% sodium fluoride, NuFluor, and Xylitol. Class II dental device (21 CFR 872.3620).

Indications for Use

Indicated for the treatment of dentin hypersensitivity in patients requiring topical fluoride application.

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.

Submission Summary (Full Text)

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

December 12, 2014

Preventive Technologies, Incorporated Mr. Kenneth S. Peterson Vice President, Research and Development 4330C Matthews-Indian Trail Road Indian Trail, North Carolina 28079

Re: K140350

Trade/Device Name: Vella 5% Sodium Fluoride Varnish with NuFluor® and Xylitol® Regulation Number: 21 CFR 872.3620 Regulation Name: Cavity varnish Regulatory Class: II Product Code: LBH Dated: November 7, 2014 Received: November 12, 2014

Dear Mr. Peterson:

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.

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Page 2 - Mr. Peterson

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## INDICATIONS FOR USE STATEMENT

(21 CFR § 807.87(h), 807.92)

510(K) Number: K140350

| Device Name: | VELLA® 5% Sodium Fluoride Varnish with<br>NuFluor® and Xylitol® |
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## Indications for Use:

Vella® 5% Sodium Fluoride Varnish with NuFluor® and Xylitol® is a topical fluoride varnish for the treatment of dentin hypersensitivity.

Prescription Use X AND/OR (21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)