ALPHA-PRO WHITE VARNISH

K124025 · Dental Technologies, Inc. · LBH · Sep 18, 2013 · Dental

Device Facts

• Record ID: K124025
• Device Name: ALPHA-PRO WHITE VARNISH
• Applicant: Dental Technologies, Inc.
• Product Code: LBH · Dental
• Decision Date: Sep 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Treatment of hypersensitive teeth.

Device Story

Alpha-Pro White Varnish is a dental cavity varnish applied by dental professionals to treat tooth hypersensitivity. The device is applied topically to the tooth surface to provide desensitization. It functions as a protective coating. Used in clinical dental settings by dentists or dental hygienists. Benefits include reduction of patient discomfort associated with sensitive teeth.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cavity varnish; class II device per 21 CFR 872.3260; product code LBH. Manufacturing adheres to ISO 9001 and ISO 13485 quality management standards.

Indications for Use

Indicated for the treatment of hypersensitive teeth in patients requiring dental desensitization.

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

September 18, 2013

Dental Technologies; Incorporated Ms. Paula Erickson Executive Vice President 6901 North Hamlin Avenue LINCOLNWOOD IL 60712

Re: K124025

Trade/Device Name: Alpha-Pro White Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: August 22, 2013 Received: August 23, 2013

Dear Ms. Erickson:

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 - Ms. Erickson

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/ReportalProblem/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,

Mary's.Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

### 510(k) Number (if known): K124025

## Device Name: Alpha-Pro White Varnish

#### Indications for use:

- Treatment of hypersensitive teeth. 황
Image /page/2/Picture/6 description: The image shows two certifications, ISO 9001 and ISO 13485. The text is stacked vertically, with "ISO 9001" on top of "ISO 13485". The text is in a bold, sans-serif font and is enclosed in a rectangular box. The certifications are likely related to quality management systems.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

Andrew I g 2013.09.18 -04'00'

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

510(k) Number: K194025

LINCOLNWOOD, ILLINOIS 60717 USA

DENTAL TECHNOLOGIES, INC.

6901 N. KAMLIN AVENUE

1.800.835.0885 TOLL FREE [USICANADA] 1.847.677.5500 PHONE [phone]. FAX