Admira is a universal, light-cured restorative material. Admira is intended to be used for the following types of restorations in both anterior and posterior teeth:

· class I-V fillings
reconstruction of traumatically affected anteriors
facetting of discolored anteriors
· correction of shape and shade to improve asthetic appearance
· locking or splinting of loose anteriors
· repairing veneers
· core build-up under crowns
· composite inlays

Device Description

Admira is a universal, light-cured restorative material based on 3dimensionally stabilized, inorganic/organic polymers (ormocers). Patentprotected ormocer chemistry provides exceptional strength, abrasion resistance, and hard tissue adhesion, while making Admira easy and fast to use. Admira further combines the benefits of silicate glass with the strength, durability, and cosmetic advantages of composites. Admira is suitable for restorations in both anterior and posterior teeth. Admira is used with Admira Bond, a bonding agent that has been specifically designed for the total-etch technique.

Admira is available in both 4gm syringes, and as pre-dosed (0.25gm) Admira Caps (composite application system) for direct intra-oral application. Admira is available in ten tooth shades.

AI/ML Overview

This document is a 510(k) summary for the dental restorative material ADMIRA®. It focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving those criteria are met for a new AI/ML device. Therefore, I cannot extract the requested information from the provided text.

Here is an explanation of why the information is not present in the document and what each bullet point would typically refer to in the context of an AI/ML device submission:

A table of acceptance criteria and the reported device performance: This document does not contain acceptance criteria for the ADMIRA® device in the format typically seen for AI/ML performance. It describes the physical and chemical properties and intended use. For an AI/ML device, this table would specify metrics like sensitivity, specificity, AUC, or other relevant performance measures (e.g., accuracy for image segmentation) and the statistical thresholds considered "acceptable."
Sample size used for the test set and the data provenance: The document does not describe a test set or its provenance for ADMIRA®. For an AI/ML device, this would detail the number of cases/images used to evaluate the final model, where this data came from (e.g., specific hospitals, geographic regions), and if it was collected retrospectively or prospectively.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to this document. For an AI/ML device, this would specify how many human experts (e.g., Board-certified radiologists) reviewed the test data to create the "correct" labels (ground truth) and their experience level.
Adjudication method for the test set: Not applicable. For an AI/ML device, this would describe the process used to resolve disagreements among experts when establishing ground truth (e.g., using a super-reader, majority vote, or separate adjudication panel).
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: Not applicable. An MRMC study evaluates the performance of human readers with and without the AI device, measuring the improvement in reader accuracy, efficiency, or other metrics. This document does not describe such a study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. A standalone study for an AI/ML device assesses the algorithm's performance on its own, without any human intervention or interpretation. While the document mentions "preclinical performance studies," it does not provide details of how these demonstrate "standalone" performance in the context of an AI/ML diagnostic tool.
The type of ground truth used: Not applicable. For an AI/ML device, this would specify if the ground truth was derived from expert consensus, histopathology, surgical findings, long-term patient outcomes, or a combination.
The sample size for the training set: Not applicable. For an AI/ML device, this would be the number of cases/images used to train the algorithm.
How the ground truth for the training set was established: Not applicable. For an AI/ML device, this would describe the methods used to label the data that the algorithm learns from, similar to point 7 but specifically for the training data.

In summary, the provided document is a 510(k) summary for a dental material, which is a very different type of medical device from an AI/ML diagnostic tool. The regulatory requirements and the information presented are therefore not aligned with what would be expected for an AI/ML device submission.

Summary

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JAN 1 2 2000

Image /page/0/Picture/1 description: The image shows a logo that spells out the word "VOCO". The letters are stylized and geometric. The "V" is an inverted triangle with a small rectangle cut out of the top. The two "O"s are circles with smaller circles cut out of the center, and the "C" is a circle with a portion cut out of it.

	VOCO GmbH · Postfach 767 · 27457 Cuxhaven		Anton-Flettner-Straße 1-327472 Cuxhaven (Germany)Telefon: (0 47 21) 719-0Telefax: (0 47 21) 719-109Telex: 2 32 202 dent d
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K994056

Ihr Zeichenyr ref.	Ihre Nachricht vomdtd.	Unser Zeichenour ref.	Datumdate
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510(k) SUMMARY

ADMIRA® (76 EBF)

- 1. SUBMITTER'S NAME
  - 1. CONTACT PERSON for VOCO GmbH
  - 1. DATE THAT 510(k) SUMMARY WAS PREPARED
  - 1. NAME OF THE MEDICAL DEVICE (Classification / Common / Proprietary)
  - 1. LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
  - 1. DESCRIPTION OF THE DEVICE
  - 1. INTENDED USE OF THE DEVICE
  - 1. TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES
  - 1. SUMMARY OF PRECLINICAL PERFORMANCE STUDIES AND CONCLUSIONS FROM PRECLINICAL PERFORMANCE STUDIES

1. SUBMITTER'S NAME
VOCO GmbHAnton-Flettner-Str. 1-327472 CuxhavenGERMANY
Tel: 011-49 47 21 719 0Fax: 011-49 47 21 719 140

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U.S. REGULATORY CONTACT PERSON FOR VOCO GmbH

Evan Dick, Ph.D. E.G. Dick & Associates 7527 Westmoreland Avenue St. Louis, MO 63105

Tel: (314) 721-0112 (314) 721-7591 Fax:

DATE THAT 510(k) SUMMARY WAS PREPARED

November 30, 1999

4. NAME OF THE MEDICAL DEVICE
Classification name	Material, tooth shade, resin(Dental 76 EBF)
Common / usual name	Light-cured dental restorative material
Proprietary names	ADMIRA®

LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED

Dyract AP (K973235, DENTSPLY) Solobond M (K980539, VOCO)

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DESCRIPTION OF THE DEVICE

Admira is available in both 4gm syringes, and as pre-dosed (0.25gm) Admira Caps (composite application system) for direct intra-oral application. Admira is available in ten tooth shades.

INTENDED USE OF THE DEVICE T

Admira is a universal, light-cured restorative material. Admira is intended to be used for the following types of restorations in both anterior and posterior teeth:

· class I-V fillings
· reconstruction of traumatically affected anteriors
· facetting of discolored anteriors
correction of shape and shade to improve asthetic appearance
· locking or splinting of loose anteriors
· repairing veneers
· core build-up under crowns
composite inlays

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TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES

ADMIRA and DYRACT AP (K973235) are both single-component, light-cured, universal composites composed of silicate glass, polyacrylic/polymethacrylic acid copolymers, photoinitiators, and stabilizers. Both products are used along with a dental bonding agent designed for the total-etch technique.

Image /page/3/Picture/4 description: The image shows the title of a document section. The title is "SUMMARY OF PRECLINICAL PERFORMANCE STUDIES AND CONCLUSIONS FROM PRECLINICAL PERFORMANCE STUDIES". The title is in bold and is centered on the page. The number 9 is to the left of the title.

Admira and Admira Bond (the bonding agent for Admira) are formulated from chemical components that are commonly associated with currently marketed dental composite materials.

The chemistry of Admira and Admira Bond raises no new issues or questions that effect safety, effectiveness, or biocompatibility for a dental composite product.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2000

VOCO GmbH c/o Evan G. Dick, Ph.D. VOCO GmbH E.G. Dick & Associates 7527 Westmoreland Avenue St. Louis, Missouri 63105

K994056 Re: Material, Tooth Shade, Resin (Dental 76 EBF) Trade Name: Requlatory Class: II Product Code: EBF November 30, 1999 Dated: November 30, 1999 Received:

Dear Dr. Dick:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate able beated in 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Dr. Dick

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K94056

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K994056

Device Name: Admira

Indications For Use:

Admira is a universal, light-cured restorative material. Admira is intended to be used for the following types of restorations in both anterior and posterior teeth:

· class I-V fillings
reconstruction of traumatically affected anteriors
facetting of discolored anteriors
· correction of shape and shade to improve asthetic appearance
· locking or splinting of loose anteriors
· repairing veneers
· core build-up under crowns
· composite inlays

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)

Nagr (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number

OR Over-The-Counter Use_

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.