Luxer Shaded Zirconia blanks/discs are intended for use with CAD/CAM technology to produce all-ceramic dental restorations (full contour crowns and bridges) as prescribed by a dentist.

Device Description

Luxer Shaded Zirconia blanks are pressed and sintered blocks of Yttria stabilized Zirconia for use in CAD/CAM milling machines. It comes in different thicknesses (12 mm - 20 mm) and classic VITA shades A-D. In order to achieve pigmentation, four basic color components are used from the TOSOH TZ-Series of zirconia {white, yellow, pink, and gray} that yield corresponding VITA shades (A-D). After the Zirconia block is milled, it is sintered into a high strength all ceramic material suitable for full contour crowns and bridges. The material is biocompatible, has a high flexural strength (>1100 Mpa), and is water insoluble. These characteristics meet the ISO standard 6872 for an esthetic dental ceramic material.

AI/ML Overview

The provided text describes the acceptance criteria and a study proving the substantial equivalence of the Luxer Shaded Zirconia device to a predicate device, as required for a 510(k) submission.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
Material Properties:
Biocompatibility	Biocompatible (stated)
High Flexural Strength	>1100 Mpa
Water Insoluble	Water Insoluble (stated)
Conformance to Standard:
ISO 6872 for esthetic dental ceramic material	Meets ISO 6872 for esthetic dental ceramic material
Substantial Equivalence:
Same fundamental technology as predicate device (K112710 ZENO Zr)	Yes, based on comparative data
Same indications for use as predicate device	Yes, intended for all-ceramic dental restorations (full contour crowns and bridges)
Similar physical properties (flexural strength, biocompatibility, solubility) as predicate device	Yes, confirmed by ISO 6872 testing
Similar chemical properties as predicate device	Yes, confirmed by ISO 6872 testing

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

Sample Size for Test Set: The document does not specify a distinct "test set" in the context of clinical or image-based studies. Instead, "non-clinical testing" was performed to validate the design and confirm conformance with ISO 6872:2008. The sample size for this non-clinical testing (e.g., number of specimens tested for flexural strength) is not explicitly stated.
Data Provenance: The data comes from "non-clinical testing" and a "Standard Data Report (Form 3654)" in relation to ISO 6872. This indicates laboratory-based, retrospective testing of material properties rather than prospective clinical data. The country of origin of the data is not specified but is implicitly associated with the applicant, Continental Dental Ceramics, Inc. (USA).

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

This information is not applicable as the study described is a non-clinical, material properties comparison study for substantial equivalence, not a study involving expert assessment of images or clinical outcomes to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the study described is a non-clinical, material properties comparison study, not one requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission focuses on the material properties and substantial equivalence of the zirconia blanks themselves, not on the performance of human readers with or without AI assistance.

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

No, a standalone algorithm-only performance study was not done. This device is a dental material (zirconia blanks), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's properties (flexural strength, biocompatibility, solubility, etc.) was established through laboratory testing against the requirements of the international standard ISO 6872:2008 for dental ceramic materials and comparison to the known properties of the predicate device.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a material science and engineering validation, not a machine learning or AI study.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

Summary

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510(k) Summary

MAY C 7 2014

Luxer Shaded Zirconia K140070

1. Date of Summary May 6, 2014 Preparation: 2. Submitting Firm: Continental Dental Ceramics, Inc. 3. Contact Person: Jerry Doviack, CDT President Continental Dental Ceramics, Inc. 1873 Western Way Torrance, CA 90501 USA jdoviack@continentaldental.com T: (310) 618-8821 F: (310) 618-1238 4. Name of Medical Device Proprietary Name: Luxer Shaded Zirconia Porcelain Powder for Clinical Use Regulation Name: Regulation Number: 872.6660 Product Code: EIH Powder, Porcelain Classification Name: Classification: Class II Panel: Dental
K112710 ZENO Zr ട്. Predicate Device: Wieland Dental + Technik GmbH & Co. KG

6. Description of Medical Device:

After the Zirconia block is milled, it is sintered into a high strength all ceramic material suitable for full contour crowns and bridges. The material is biocompatible, has a high flexural strength (>1100 Mpa), and is water insoluble. These characteristics meet the ISO standard 6872 for an esthetic dental ceramic material.

510(k) Summary

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7. Intended Use

Luxer Shaded Zirconia blanks/discs are intended for use with CAD/CAM technology to produce all-ceramic dental restorations (full contour crowns and bridges) as prescribed by a dentist.

Substantial Equivalence 8.

Continental Dental believes that Luxer Shaded Zirconia blanks are substantially equivalent to other legally marketed devices in the United States, such as K112710 ZENO Zr, Wieland Dental + Technik Gmbh & Co. KG. Both Luxer Shaded blanks and the predicate device are made from porcelain powder (product code EIH) and exhibit similar physical and chemical properties.

In comparison to the predicate, using ISO standard 6872 the data from that testing concludes that both materials are fundamentally the same. They both have the same fundamental technology, indications for use, physical properties (flexural strength, biocompatibility, solubility) and other technical similarities.

Based on the comparative data, Luxer Shaded Zirconia is essentially the same as currently marketed devices for the same indication, with similar physical and chemical properties, and supports our claim for substantial equivalence.

ರು Non-Clinical Testing

Non-clinical testing was performed in order to validate the design against the company's specified design requirements for physical and chemical properties, as well as flexural strength, and to assure conformance with the voluntary design standard ISO 6872:2008. Please see attached Standard Data Report (Form 3654).

10. Biocompatibility

Biocompatibility testing was not performed since identical materials are used in the predicate device with the same type and duration of patient contact. Our device is comprised of identical materials and manufacturing methods as the predicate device and other legally marketed devices and does not introduce any new issues of safety or effectiveness.

11. Safety & Effectiveness

The successful prior use of the components of Luxer Shaded Zirconia product in legally marketed devices, the similarity of the formulations used in this device and earlier devices, and the substantially equivalence of Luxer Shaded Zirconia blanks to prior cleared devices support the safety and effectiveness of this product for the intended use.

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It has been shown in this 510(k) submission that the difference between Luxer Shaded Zirconia discs and the predicate device do not raise any questions regarding its safety and effectiveness.

END OF SECTION

510(k) Summary

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures connected in a flowing, dynamic design.

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

May 7, 2014

Continental Dental Ceramics, Incorporated Mr. Jerry Doviack, CDT President 1873 Western Way Torrance, CA 90501

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Re: K140070

Trade/Device Name: Porcelain Powder for Clinical Use Regulation Number: 21 CFR 872.6660 Regulation Name: Powder, Porcelain Regulatory Class: II Product Code: EIH Dated: April 30, 2014 Received: May 1, 2014

Dear Mr. Doviack:

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.

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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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

MarySRunner-S

Erin 1. Keith, M.S. Acting 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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Indications for Use

510(k) Number (if known): __K140070

Device Name: Luxer Shaded Zirconia

Range of Indications:

Luxer Shaded Zirconia blanks are intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns and bridges) as prescribed by a dentist.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

She 2014.05.07 14

Indications for Use

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.