Based on the provided information, the device is claiming substantial equivalence to predicate devices based on comparisons of formulations, mechanical characteristics, and intended uses.

Therefore, there is no acceptance criteria based on performance metrics for the device, and no study that demonstrates the device meets such criteria. The FDA cleared the device based on its substantial equivalence to legally marketed predicate devices without requiring performance data.

The sections below are filled out as "N/A" (Not Applicable) because the submitted document explicitly states "Performance Data: None required."

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
N/A	N/A	Performance data was not required for this 510(k) submission. Substantial equivalence was based on formulations, mechanical characteristics, and intended uses compared to predicate devices.

2. Sample size used for the test set and the data provenance

N/A - No performance test set or data provenance is mentioned as performance data was not required.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A - No ground truth or experts were involved in establishing performance for this device, as performance data was not required.

4. Adjudication method for the test set

N/A - No test set or adjudication method is mentioned as performance data was not required.

5. 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

N/A - This device is a dental material, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

N/A - This device is a dental material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

N/A - No ground truth information related to performance is provided, as performance data was not required.

8. The sample size for the training set

N/A - No training set is mentioned as performance data was not required.

9. How the ground truth for the training set was established

N/A - No training set or ground truth establishment is mentioned as performance data was not required.

Summary

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FEB - 2 2007

EXHIBIT 2 510(k) SUMMARY: Amann Girrbach America, Inc. Ceramill Zi Blanks

This 510(k) summary of safety and effectiveness for Amann Girbach America, Inc. Ceramill Zi Blank material is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Applicant: Amann Girrbach America, Inc

Address: 12169 Villa Road Spring Hill, FL 34609 Tel 800 851-3719 Fax 352-398-1409 Contact Person: Ms. Amanda Clark
Manufacturer: Amann Girrbach GmbH Herschaftsweisen 1 Koblach 6842-A Austria

Preparation Date: November 16, 2006

Device Name: Ceramill Zi Blank Common Name: Dental Frame Material for Dental Prosthesis Classification: Porcelain, powder for clinical use 21 CFR 872.6660 Class II medical device Product Code: EIH Panel: 76

Predicate devices: KaVo Everest ZS-Blank K03281 and 3M "Lava" K053438 and Vident VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL2 K052130 and ZIRKONZAHN GMBHZIRKONZAHN ICE K061851, among others.
Device description: The Ceramill Zi Blank is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics
Indications: The Ceramill Zi Blank is used in the manufacture of dental prosthetics.
Performance Data: None required. The claim of substantial equivalence is based on comparisons of formulations, mechanical characteristics, and intended uses of the devices to legally marketed predicates and to the IDENTIFICATION of porcelain powders in 21 CFR 872.6660.
CONCLUSION: Based on the information in the notification Amann Girrbach America, Inc believes that Ceramill Zi Blank is substantially equivalent to cited legally marketed predicates and to the IDENTIFICATION in the classifying regulation (21 CFR 872.6660).

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is black and has a simple, modern design. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Amann Girrbach America, Incorporated C/O Mr. Daniel Kamm Principal Consultant Kamm & Associates P.O. Box 7007 Deerfield Illinois 60015

FEB - 2 2007

·Re: K063511

Trade/Device Name: Ceramill Zi Blanks Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 16, 2006 Received: November 21, 2006

Dear Mr. Kamm:

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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Page 2 - Mr. Kamm

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-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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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K063511

Indications for Use

KOlo 35) 510(k) Number (if known):

Device Name: Ceramill Zi blanks .

Indications for Use:

Amann Girrbach America, Inc. Ceramill Zi blanks are used in the manufacture of dental prosthetics.

Prescription Use C (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suser Runse

( ग्राहाज्या (आहे. 18) Onvision of Anonhestology Forneral Hospital I Tarilon Control, Dental Devices

Page 1 of 1

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.