K Number
K061823
Device Name
ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE
Manufacturer
Date Cleared
2006-07-21

(23 days)

Product Code
Regulation Number
872.3765
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- treatment of hypersensitive dentine - treatment of cervical areas (including crown margins, after tooth cleaning or tartar removal, exposed cervical areas etc.)
Device Description
Not Found
More Information

Not Found

Not Found

No
The provided text does not mention AI, ML, or any related concepts like image processing, deep neural networks (DNNs), or training/test sets which are typically associated with AI/ML medical devices. The intended use and anatomical site descriptions are for a dental treatment device, which doesn't inherently suggest AI/ML involvement.

Yes
The device is intended for the "treatment of hypersensitive dentine" and "treatment of cervical areas," indicating a therapeutic purpose to alleviate symptoms or treat a condition.

No
Explanation: The intended use of the device is for the "treatment of hypersensitive dentine" and "treatment of cervical areas," which refers to therapeutic/treatment applications, not diagnostic ones.

Unknown

The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended uses listed are "treatment of hypersensitive dentine" and "treatment of cervical areas". These are direct treatments applied to the patient's body (dentine and cervical areas of teeth).
  • IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside the body to provide information about a person's health.

This device's function is therapeutic and applied directly to the patient, not for testing samples in a lab setting.

N/A

Intended Use / Indications for Use

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

Product codes

EBC

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

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.

1

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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

2

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