ADMIRA SEAL by VOCO GMBH | FDA 510(k) Summary

This FDA document is a 510(k) clearance letter for the "Admira Seal" device, a pit and fissure sealant. It does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/ML device.

The document grants market clearance based on substantial equivalence to legally marketed predicate devices, a regulatory pathway that typically relies on demonstrating that the new device is as safe and effective as a legally marketed device that is not subject to PMA. This usually involves comparing device characteristics (e.g., materials, design, intended use) and performance data from internal testing or literature reviews, rather than clinical studies with detailed acceptance criteria and expert-adjudicated ground truth as would be expected for AI/ML performance evaluation.

Therefore, I cannot fulfill your request for the specific details outlined (acceptance criteria, study details, sample sizes, expert qualifications, ground truth, etc.) because this information is not present in the provided text. The document simply states that the device is substantially equivalent and thus cleared for market.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2002

VOCO GmbH C/O Mr. Gerald W. Shipps Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702

Re: K021842

Trade/Device Name: Admira Seal Regulation Number: 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: May 28, 2002 Received: June 05, 2002

Dear Mr. Shipps:

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 III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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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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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski 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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510(k) Number: K021842

Device Name: Admira Seal

Indications for Use:

Sealing/filling of pits and fissures as well as small cavities ●
Sealing/facing of damaged enamel surfaces ●
Anchorage of orthodontic appliances .
Sealing of composites or cement fillings .
Restoration of small defects in composites and amalgam fillings ●
Sealing of deciduous teeth .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﻤﺎ ﻳﻮﻧﻴﻮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ Prescription Use

Over-The-Counter Use

Rohit Shelat DDS for Dr. Susan Kummer

ction Control,

Regulation Number and Section

§ 872.3765 Pit and fissure sealant and conditioner.

(a)
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.(b)
Classification. Class II.