Zher mack OCCLUFAST ROCK a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a dental impression material, Occlufast Rock. The document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. This type of document does not typically contain detailed study data, acceptance criteria, or performance metrics in the way a clinical trial report or a performance study summary for an AI/ML device would.

Therefore, most of the requested information cannot be extracted from the provided text. The document confirms that the device is an "Impression Material" (Regulation Number: 872.3660, Regulation Name: Impression Material, Regulatory Class: II, Product Code: ELW). Its intended use is "a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums."

Here's a breakdown of what can and cannot be answered based only on the provided text:

A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document is a regulatory approval letter based on substantial equivalence, not a performance study report. It does not list specific acceptance criteria or reported performance values.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. This information is absent from the regulatory approval letter.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be provided. This information is absent from the regulatory approval letter. The "ground truth" for a dental impression material would likely relate to its physical properties (dimensional stability, accuracy, tear strength, etc.) and clinical performance, not expert image interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. This information is absent from the regulatory approval letter.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be provided. This is not an AI/ML device, and therefore MRMC studies for AI assistance are not relevant. The device is a traditional dental impression material.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Cannot be provided. This is not an AI/ML device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Cannot be provided definitively from this document. While not explicitly stated, for an impression material, the "ground truth" for its performance would likely involve objective measurements of physical properties (e.g., dimensional accuracy, setting time, tear resistance) and possibly clinical evaluations of impression quality, rather than expert consensus on diagnostic images or pathology. The document only states it's intended "to reproduce the structure of a patient's teeth and gums," implying the ground truth would be the actual tooth and gum structure it needs to replicate accurately.
The sample size for the training set:
- Cannot be provided. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established:
- Cannot be provided. This is not an AI/ML device, so there is no "training set."

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health.

Public Health Service

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2002

Zhermack S. P. A. C/O Mr. Gerald W. Shipps Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702

Re: K024034

Trade/Device Name: Occlufast Rock Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: December 2, 2002 Received: December 6, 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 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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- Mr. Shipps

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 (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.

Patrice Cicante /fr

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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Indications for Use Statement

510(k) Number:

OCCLUFAST ROCK

Device Name:

Indications for Use:

Zher mack OCCLUFAST ROCK a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use سر

Over-The-Counter Use

2-1

Susan Roper

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

Kut. 402 510(k) Number

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).