ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE

K061823 · Voco GmbH · EBC · Jul 21, 2006 · Dental

Device Facts

• Record ID: K061823
• Device Name: ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE
• Applicant: Voco GmbH
• Product Code: EBC · Dental
• Decision Date: Jul 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

treatment of hypersensitive dentine • treatment of cervical areas (including crown margins, after tooth cleaning or tartar removal, exposed cervical areas etc.)

Device Story

Admira Protect and Admira Protect Single Dose are dental materials used for the treatment of hypersensitive dentine and cervical areas, such as crown margins and exposed cervical regions following professional tooth cleaning or tartar removal. The device is applied by dental professionals in a clinical setting. It functions as a desensitizing agent to alleviate patient discomfort associated with dentinal hypersensitivity. By treating exposed cervical areas, the device helps protect the tooth structure and reduce sensitivity, thereby improving patient comfort and oral health outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Pit and fissure sealant and conditioner; product code EBC; regulatory class II. Specific material composition and physical standards are not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring treatment of hypersensitive dentine and cervical areas, including crown margins and exposed cervical areas following procedures like tooth cleaning or tartar removal.

Regulatory Classification

Identification

A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized design featuring four abstract human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 1 2006

Dr. Michael Süs Manager for Regulatory Affairs VOCO GmbH Anton-Flettner-Strasse 1-3 Cuxhaven. Germany 27472

Re: K061823

Trade/Device Name: Admira Protect and Admira Protect Single Dose Regulation Number: 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: June 26, 2006 Received: June 28. 2006

Dear Dr. Süs:

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 HI (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. În addition. FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 Dr. Michael Süs

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-fice number [phone] or [phone] or at its Internet address http://www.fda.gov/edrh/industry/support/index.html.

Sincerely vours.

Chiu Lin. Ph.D.

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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## Indications for Use Statement

510(k) Number: K061823

Device Name: Admira Protect and Admira Protect Single Dose J

Indications for Use:

- treatment of hypersensitive dentine •
- treatment of cervical areas (including crown margins, after tooth cleaning or tartar removal, exposed cervical areas etc.)

Prescription Use __X

OR

Over-The-Counter Use _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Koledshetzous for Dr. Aaron Kanner
(sign-off)

esthesiblogy. General Hospital

Number KC61823