The CARRARA INTERACTION CERAMIC SYSTEM is a dental porcelain system used for the preparation of fixed prosthodontic devices. The CARRARA INTERACTION CERAMIC SYSTEM consists of Paste Opaque, Dentine, Enamel, Margin, and Glaze porcelains.

AI/ML Overview

The provided text describes a 510(k) summary for the "CARRARA INTERACTION CERAMIC SYSTEM," a dental porcelain system. However, it does not contain specific information about acceptance criteria or a study proving the device meets those criteria, as typically found in reports detailing performance data, statistical analysis, or clinical trials for medical devices with measurable outputs.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices, the intended use, and the technological characteristics, highlighting that the components have been previously marketed and that the product itself has been on the European market.

Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document.

Here's an attempt to answer based on the absence of information in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document	Not specified in the document

Explanation: The document does not provide any specific quantitative acceptance criteria (e.g., strength, wear resistance, color stability) or reported performance metrics against such criteria. The submission relies on the concept of "substantial equivalence" to predicate devices and historical market use.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable/Not specified. The document does not describe a "test set" of data or a specific study with a defined sample size for performance evaluation.
Data Provenance: The document mentions that the system has been on the European market since 2002 with "over 1 million units placed." This implies historical market data and experience, but not a controlled "test set" for a specific study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts: Not applicable/Not specified.
Qualifications of Experts: Not applicable/Not specified.

Explanation: Since no specific test set or study is described, there's no mention of experts establishing a ground truth.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable/Not specified.

Explanation: No test set is described, so no adjudication method is relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done or at least not described in this document.

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

Not applicable. This is a dental material (porcelain system), not a software algorithm or an AI device.

7. The Type of Ground Truth Used:

The concept of "ground truth" as typically used for diagnostic devices (e.g., pathology, outcomes data) is not applicable here. The device is a dental material for restorative systems. Its "ground truth" would be related to its physical, chemical, and biological properties, as well as its clinical performance over time, which are inferred through comparison to predicate devices and historical use, rather than a specific "ground truth" dataset for performance evaluation.

8. The Sample Size for the Training Set:

Not applicable/Not specified. As this is a dental material, not a machine learning model, the concept of a "training set" is not relevant.

9. How the Ground Truth for the Training Set was Established:

Not applicable/Not specified. The concept of a "training set" and its "ground truth" is not relevant to this type of device.

Summary of what can be inferred from the document:

The submission relies heavily on:

Substantial equivalence: The "CARRARA INTERACTION CERAMIC SYSTEM" is described as "very similar in formulation to legally marketed dental ceramics" and produced from the same frits as predicate devices (Elephant's Carrara K981000 and Antagon K982129 Ceramics).
Prior market history/experience: The device has been on the "European market since 2002 with over 1 million units placed."
Prior use of components: "All of the components found in the CARRARA INTERACTION CERAMIC SYSTEM have been used in legally marketed devices."

The document states: "We believe that the prior use of the components of the CARRARA INTERACTION CERAMIC SYSTEM in legally marketed devices, the performance data provided, and the historical use of the device in Europe support the safety and effectiveness of the CARRARA INTERACTION CERAMIC SYSTEM for the intended use." This suggests that "performance data provided" refers to the formulation similarity and the successful market use rather than explicit, detailed, quantitative studies with defined acceptance criteria.

Summary

{0}------------------------------------------------

510(k) SUMMARY

MAR 3 0 2004

DENTSPLY International World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 P. J. Lehn Telefax (717) 849-4343

1 0635

P. Jeffery Lehn CONTACT:

March 8, 2004 DATE PREPARED:

TRADE OR PROPRIETARY NAME: CARRARA INTERACTION CFRAMIC SYSTEM

CLASSIFICATION NAME: Porcelain powder for clinical use (872.6660)

Carrara Porcelain and Carrara Vincent Porcelain K981000 PREDICATE DEVICES:

The CARRARA INTERACTION CERAMIC SYSTEM is a dental DEVICE DESCRIPTION: porcelain system used for the preparation of fixed prosthodontic devices.

The CARRARA INTERACTION CERAMIC SYSTEM consists of Paste Opaque, Dentine, Enamel, Margin, and Glaze porcelains.

INTENDED USE: The CARRARA INTERACTION CERAMIC SYSTEM is indicated for veneering of metal-ceramic or full ceramic restorative systems.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in the CARRARA INTERACTION CERAMIC SYSTEM have been used in legally marketed devices.

The CARRARA INTERACTION CERAMIC SYSTEM is very similar in formulation to legally marketed dental ceramics and has been on the European market since 2002 with over 1 million units placed. The CARRARA INTERACTION CERAMIC SYSTEM is produced from the same frits as Elephant's Carrara (K981000) and Antagon (K982129) Ceramics. Elephant veneering ceramics have been on the market since 1984. Therefore, it was determined that no biocompatibility testing was necessary.

We believe that the prior use of the components of the CARRARA INTERACTION CERAMIC SYSTEM in legally marketed devices, the performance data provided, and the historical use of the device in Europe support the safety and effectiveness of the CARRARA INTERACTION CERAMIC SYSTEM for the intended use.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2004

Mr. P. Jeffery Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, Pennsylvania 17405-0872

Re: K040635

Trade/Device Name: Carrara Interaction® Ceramic System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: March 08, 2004 Received: March 10, 2004

Dear Mr. Lehn:

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.

{2}------------------------------------------------

Page 2 - Mr. P. Jeffery Lehn

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) you may obtain. 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,

Chris S. Jenkins, Ph.D.

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

040635 510(K) Number (if known):

Device Name:

CARRARA INTERACTION CERAMIC SYSTEM

Indications for Use:

The CARRARA INTERACTION CERAMIC SYSTEM is indicated for veneering of metal-ceramic or full ceramic restorative systems.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suver Ruay

sion of Anesthesiology, General Hospital, Infection Control. Der

510(k) Number

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.