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

Dental Blanks made from StarCeram® Z-Smile are indicated for crowns and bridges, multi-unit bridges, inlay bridges and all-ceramic restoration as max three-unit bridge at the anterior and posterior area.

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. StarCeram® Z-Smile and StarCeram® Z-Nature are a modification to the StarCeram® products that have already been cleared by the Food and Drug Administration in K133213 and K140924. StarCeram® Z-Smile and StarCeram® Z-Nature have the same intended use and fundamental scientific technology as the StarCeram® products previously cleared by FDA. The only change between the cleared products and the new products is the addition of new color qualities.

AI/ML Overview

This document is a 510(k) summary for the StarCeram® Z-Nature and StarCeram® Z-Smile dental blanks. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a study. Therefore, most of the requested information regarding study details (e.g., sample size, expert ground truth, adjudication, MRMC studies) is not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the format typically seen for a new device's performance claims. Instead, it relies on demonstrating that the new devices have similar technological characteristics and meet general standards as their predicate devices. The key performance characteristic mentioned for comparison is Flexural Strength.

Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (StarCeram® Z-Nature/Z-Smile)
Flexural Strength:
K133213 Predicates: 1,000 +/- 200 MPa	Z-Nature: 1,000 +/- 200 MPa
K150196 (DD cubeX2): >720 MPa	Z-Smile: >500 MPa
Biocompatibility/Cytotoxicity:	Complies with ISO 10993-1 and ISO 10993-5
(Implied: Meets ISO standards)

Explanation of Performance:

For StarCeram® Z-Nature, the flexural strength is identical to its predicate devices (K133213 and K140924).
For StarCeram® Z-Smile, the flexural strength (>500 MPa) is stated to be "exactly as required by DIN EN ISO 6872 for Class 5 dental ceramics (>500MPa)", thus demonstrating equivalence to its predicate DD cubeX2 which has >720 MPa. The slightly lower value for Z-Smile is considered acceptable because it still meets the relevant standard.
Biocompatibility and cytotoxicity were tested to ensure compliance with relevant ISO standards, aligning with the implied standards for predicate devices.

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

Not applicable. This document describes a 510(k) premarket notification, which typically relies on comparisons to predicate devices and adherence to recognized standards, not clinical trials with test sets in the context of AI/medical device performance evaluation.
The "Non-clinical Testing" section mentions "Biocompatibility and cytotoxicity testing was performed," but does not provide details on sample size or data provenance (e.g., country of origin, retrospective/prospective). The study was likely conducted under Design Controls.

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

Not applicable. No clinical test set with human subject data requiring expert ground truth or adjudication is described.

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

Not applicable. No clinical test set.

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:

Not applicable. This is a material (dental ceramic blank) submission, not an AI device. No MRMC study was performed.

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

Not applicable. This is not an AI algorithm.

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

Not applicable for clinical ground truth. The "ground truth" in this context is adherence to recognized standards for material properties (e.g., Flexural Strength, biocompatibility), which are measured through laboratory testing, not human-derived ground truth.

8. The sample size for the training set:

Not applicable. This is a material device, not an AI device that requires a training set.

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

Not applicable. As above, no training set.

In summary:

This 510(k) submission primarily demonstrates "substantial equivalence" based on:

Similar intended use and indications for use.
Similar fundamental scientific technology (yttrium stabilized pre-sintered zirconium dioxide).
Similar technological characteristics and performance specifications (e.g., flexural strength meeting or exceeding relevant ISO/DIN standards, biocompatibility testing in compliance with ISO standards).
The key change for these new products (StarCeram® Z-Nature and Z-Smile) compared to their predicates is "the addition of new color qualities."
"No clinical testing was performed" for this submission, as the changes were deemed not to warrant new human clinical studies given the existing predicate data and adherence to material standards.

Summary

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

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 9, 2015

H.C. Starck Ceramics GmbH c/o Ms. Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864

Re: K143656

Trade/Device Name: StarCeram® Z-Nature, StarCeram® Z-Smile Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: June 10, 2015 Received: June 11, 2015

Dear Ms. O'Connell:

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. 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.

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

Page 2 - Ms. Maureen 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 electronic 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/Resourcesfor You/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/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/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 yours,

Tina
Kiang-S

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

Enclosure

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

Indications for Use

510(k) Number (if known) K143656

Device Name StarCeram® Z-Nature StarCeram® Z-Smile

Indications for Use (Describe)

Dental Blanks made from StarCeram® Z-Nature are indicated for crowns, multi-unit bridges and allceramic restoration. Applications include both anterior and posterior bridges.

Dental Blanks made from StarCeram® Z-Smile are indicated for crowns and bridges, inlay bridges and all-ceramic restoration as max three-unit bridge at the anterior and posterior area.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) SUMMARY K143656

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 (978) 207-1245 Phone: Facsimile: (978) 824-2541

Date Prepared: July 6, 2015

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

StarCeram® Z-Nature StarCeram® Z-Smile

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 Porcelain powder for clinical use

Predicate Devices Primary Predicate StarCeram® products cleared in K133213

Reference Predicates StarCeram® Z-Med TransColour Red (K140924) DD cubeX2 (K150196)

{4}------------------------------------------------

Intended Use / Indications for Use

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

Device Description

Non-clinical Testing

Biocompatibility and cytotoxicity testing was performed which showed that all versions of the product comply with ISO 10993-1 and ISO 10993-5. Biocompatibility testing was performed under Design Controls to show that the modified version of the product continued to comply with the recognized consensus standards.

Clinical Testing

No clinical testing was performed.

ProductName	StarCeram®Z-Nature andZ-Smile	StarCeram® Z-Med,StarCeram® Z-Al-Med HD,StarCeram® Z-Al-Med-HDColour,StarCeram® Z-Al-Med HDTranslucent,StarCeram® Z-MedTransColour	StarCeram® Z-MedTransColourRed	DD cubeX2 andaccessories
-----------------	---------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------	------------------------------

Substantial Equivalence

{5}------------------------------------------------

510(k) Number	K143656	K133213	K140924	K150196
Product Code	EIH	EIH	EIH	EIH
Product Description	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 machines.	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 machines.	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 machines.	DD cubeX2 is a semi-finished dental blank made of yttrium stabilized pre-sintered zirconium dioxide, which has a super high translucency. The ceramics is of type II (not powder), Class 5 according to DIN EN ISO 6872 (FDA Recognition Number 4-178). The DD cubeX2 dental blanks are designed for milled production of crowns and bridge frameworks on commercial CAD/CAM systems or hand-operated copy milling machines.
Material	Yttrium stabilized zirconium dioxide	Yttrium stabilized zirconium dioxide	Yttrium stabilized zirconium dioxide	Yttrium stabilized zirconium dioxide
Availability	Various colors, translucencies and thicknesses	Various colors, translucencies and thicknesses	Various colors, translucencies and thicknesses	Various colors, translucencies and thicknesses
Flexural Strength	Z-Smile >500Z-Nature 1,000 +/- 200	1,000 +/- 200	1,000 +/- 200	>720

H.C. Starck's StarCeram® Z-Smile and StarCeram® Z-Nature are modifications to the StarCeram® products cleared in K133213 and K140924. StarCeram® Z-Nature has the same intended use and indications for use,

{6}------------------------------------------------

principles of operation, and similar technological characteristics as the previously cleared predicate devices. StarCeram® Dental Blanks are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include anterior and posterior bridges. This is the exact indications for use statement cleared for StarCeram® in K133213 and K140924. Thus, StarCeram® Z-Nature has the same intended use and may be substantially equivalent.

StarCeram® Z-Smile is also substantially equivalent to the DD cubeX2 cleared in K150196. StarCeram® Z-Smile has the same intended use also allowing a maximum of 3 bridges to be constructed using the product. The flexural strength of StarCeram Z-Smile is slightly lower than the predicate, but exactly as required by DIN EN ISO 6872 for Class 5 dental ceramics (>500MPa). Therefore, STARCERAM Z-Smile is substantially equivalent to the DD cubeX2 cleared in K150196.

StarCeram® Z-Smile and StarCeram® Z-Nature have the same technological characteristics as the predicate devices. All of the devices are yttrium stabilized pre-sintered zirconium dioxide to be used in dental restorations. The StarCeram® products cleared in K133213 and K140924, and StarCeram® Z-Smile and StarCeram® Z-Nature are all dental blanks which are fabricated to the desired shape by the user based on the specific needs of the patient.

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.