Dental Blanks made from StarCeram® are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges.

Device Description

Dental blanks made from StarCeram® products are semi finished products made of yttrium stabilized pre-sintered zirconium dioxide for milled production of crowns and bridge framework on commercial CAD/CAM systems or hand-operated copy-milling.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a dental blank device, StarCeram®, and primarily addresses substantial equivalence to predicate devices, not performance criteria in the context of an AI/ML medical device. As such, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth is not applicable.

Here's an analysis based on the provided text, addressing the relevant points and indicating where information is not present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
No specific performance acceptance criteria for the device's output (e.g., diagnostic accuracy, sensitivity, specificity) are mentioned in this document. The submission focuses on substantial equivalence to existing predicate devices.	Biocompatibility and cytotoxicity testing showed that all versions of the product comply with ISO 10993-1, demonstrating the material's safety for use in the human body.
For the previously cleared StarCeram® Z-Med and Z-Al-Med HD (K081263), the only change to the cleared products is the additional indication for use related to all-ceramic restoration. All other aspects, including physical properties, remain unchanged.	(No specific performance data is provided for this added indication, relying on substantial equivalence to the original clearance.)
For StarCeram® Z-Al-Med-HD Colour, StarCeram® Z-Al-Med HD Translucent, and StarCeram® Z-Med TransColour, the primary difference from the predicate is the exact combination of qualities of zirconium dioxide used. All other physical properties are identical to the StarCeram® products cleared in K081263.	(No specific performance data is provided for these material variations, relying on biocompatibility and substantial equivalence.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the submission does not describe a clinical study measuring device performance in the context of diagnostic accuracy or similar metrics. The "Performance Data" section explicitly states, "No performance data was required or provided." The evaluation focused on biocompatibility and substantial equivalence.

3. 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)

This information is not applicable. No test set or ground truth in the context of a diagnostic or therapeutic AI/ML device is mentioned. The assessment revolved around material properties and comparison to predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable.

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

This information is not applicable. The device is a dental blank, not an AI/ML diagnostic or assistive tool for human readers.

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

This information is not applicable.

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

This information is not applicable. The "ground truth" in this context would be the successful demonstration of biocompatibility per ISO standards and the physical properties aligning with predicate devices, rather than a clinical ground truth for a diagnostic task.

8. The sample size for the training set

This information is not applicable. No AI/ML model training is described.

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

This information is not applicable.

Summary

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· 510(k) SUMMARY

H.C. Starck Ceramics GmbH StarCeram®

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Phone: (978) 207-1245 Facsimile: (978) 824-2541

DEC 0 5 2013

November 6, 2013 Date Prepared:

Name of Device and Name/Address of 510(k) Owner

StarCeram® Z-Med StarCeram® Z-Al-Med HD StarCeram® Z-Al-Med HD Colour StarCeram® Z-Al-Med-HD Translucent StarCeram® Z-Med TransColour

H.C. Starck Ceramics GmbH Lorenz-Hutschenreuther-Str. 81 95100 Selb, Germany

Common or Usual Name

Powder, Porcelain

Classification Name

21 C.F.R. 872.6660

Predicate Devices

StarCeram Z-Med and Z-Al-Med HD (K081263) ZENO Zr Disc (K112710)

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Intended Use / Indications for Use

Dental Blanks made from StarCeram® are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges. "

Technological Characteristics

Performance Data

No performance data was required or provided. Biocompatibility and cytotoxicity testing was performed which showed that all versions of the product comply with ISO 10993-1.

Substantial Equivalence

StarCeram® Z-Med and StarCeram® Z-Al-Med HD were previously cleared in K081263. The only change to the cleared products is the additional indication for use related to all-ceramic restoration. All other aspects of the product including physical properties remain unchanged compared to the product cleared in K081263.

Regarding StarCeram® Z-Al-Med-HD Colour, StarCeram® Z-Al-Med HD Translucent, and StarCeram® Z-Med TransColour, these are dental blanks which are fabricated to the desired shape by the user based on the specific needs of the patient. The only difference between these three new products and the two StarCeram® products cleared in K081263 is the exact combination of qualities of zirconium dioxide used in each product. All other physical properties are identical to the StarCeram® products cleared in K081263.

Regarding the ZENO Zr Disc predicate device cleared in K112710, these products are also a group of medical devices which are discoidal shaped and partially sintered dental ceramic materials that are composed of zirconium dioxide. They are also available in various colors, translucencies and thicknesses. These blanks are also processed by the user based on the specific needs of the patient. The ZENO Zr Disc products are provided in 7 colors and a variety of thicknesses ranging from 10 to 25 mm which is the exact range of thicknesses offered for the StarCeram® products.

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The only difference between the StarCeram® Z-Al-Med-HD Colour, StarCeram® Z-Al-Med HD Translucent, and StarCeram® Z-Med TransColour products and the StarCeram® products cleared in K081263 is the exact formulation of zirconium dioxide used. These differences have been addressed by performing biocompatibility testing which was provided in the 510(k) and showed that all versions of the product were found to be biocompatible. Therefore, the differences do not affect the safety or effectiveness of the products.

Similarly, when comparing the StarCeram® products to the ZENO Zr Disc predicate device cleared in K112710, the differences are the exact shapes of blanks offered and the exact formulation of zirconium dioxide utilized in each version of the product. The differences in the exact shapes of blanks available does not affect the safety or effectiveness of the product as the user chooses the blank that meets the needs of the patient and then processes the blank to the shape needed. Regarding the exact formulation of zirconium dioxide utilized in the StarCeram® products and the ZENO Zr Disc products, both product lines use a variety of formulations to achieve a range of colors and translucencies. These differences have been addressed in the biocompatibility testing which was provided in the 510(k) which showed that all versions of the products were found to be biocompatible. Therefore, the differences do not affect the safety or effectiveness of the products.

Therefore, StarCeram® products are substantially equivalent to the identified predicate devices because they have the same intended use and technological characteristics including materials, application process and biocompatibility.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol of three wavy lines, resembling an abstract representation of a human figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Glad Silver Spring, MD 20493-0002

December 5, 2013

H.C. Starek Ceramics GmbH C/O Ms. Maureen O Connell Regulatory Consultant O Connell Regulatory Consultants, Inc. 5 Timber Lanc North Reading, MA 01864

Re: K133213

Trade/Device Name: StarCeram Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: Ell-I Dated: November 6. 2013 Received: November 7. 2013

Dear Ms. O'Connell:

We have reviewed vour 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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 -Ms. O'Connell

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable. the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesTorYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/McdicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Kwame O. Ulmer -S

for

Erin I. Keith M.S. Acting Division Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K133213

Indications for Use Statement

. .

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

StarCeram® Device Name:

Indications for Use:

Dental Blanks made from StarCeram® are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges.

Prescription Use _ X (Part 21 C.F.R. 801 Subpart D) Subpart C)

AND/OR

Over-The-Counter Use (21 C.F.R. 807

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Mary S. Runner -S 2013.12.04 13:44:57 -05'00'

ક્ષ્દ

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.