The dental ceramic ceramics2in1 is a low fusing dental ceramic sinter material for the production of crowns and bridges made of zirconium oxide or titanium based coping and frameworks.

The system comprises ceramic materials typical for dental ceramics: shoulder margin, opaque, opaque dentin, dentin, incisal, effect, opal, gingiva, addon correction material, stains, shades, glaze and liquids

Veneering of titanium copings / frameworks -
-Veneering of zirconium oxide based copings / frameworks

Device Description

The ceramics2in1 is a porcelain powder system for bonding to titanium or zirconium dental frameworks or copings. The device is used in prosthetic dentistry by heating in an oven to produce a hard prosthesis with a glass-like finish.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
ISO 6872 (Solubility)	Within the limits of the standard; not significantly different to predicate device.
ISO 6872 (Bond Strength)	Within the limits of the standard; not significantly different to predicate device.
ISO 6872 (Flexural Strength)	Within the limits of the standard; not significantly different to predicate device.
Biocompatibility	No unacceptable toxic or allergic potential; Considered highly biocompatible; No unacceptable health risks.

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are primarily focused on material properties rather than clinical performance trials with human subjects.

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

This information is not applicable/not provided in the context of the material property tests described. The ground truth for these tests would be the measurement results against established ISO standards, not expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, which are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided text. The submission focuses on material equivalence to a predicate device, not on comparing human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable/not provided. The device is a dental ceramic material, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for the reported performance metrics (solubility, bond strength, flexural strength) was based on established international standards (ISO 6872). For biocompatibility, it was based on an evaluation against current knowledge regarding health risks.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a material, not a machine learning model, so there is no concept of a "training set" in this context.

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

This information is not applicable/not provided for the same reasons as #8.

Summary

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510(k) Summary

ﺑ

MAY 2 5 .

510(k) Summary

100150

owner's name:	Biodenta Swiss AG
address:	Tramstrasse 169442 BerneckSwitzerland
phone:	+41 71 747 11 11
fax numbers:	+41 71 747 1112
name of contact person:	Mr. David Eiler
date the summary was prepared:	2010-05-19
name of the device:	ceramics2in1
trade or proprietary name:	ceramics2in1
the classification name:	powder, porcelain
	(21 CFR 872.6660; Product Code EIH)
Legally marketed device to which yourfirm is claiming equivalence	The following predicate device is used to showthe substantial equivalence concerning thegeneral design of the ceramics2in1 system
company:	Dentaurum, Inc.
device:	Triceram
510(k) No.:	K011428

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Indications for Use:

The dental ceramic ceramics2in1 is a low fusing dental ceramic sinter material for the production of crowns and bridges made of zirconium oxide or titanium based coping and frameworks. The system comprises ceramic materials typical for dental ceramics: shoulder margin, opaque, opaque dentin, dentin, incisal, effect, opal, gingiva, addon correction material, stains, shades, glaze and liquids

l Veneering of titanium copings / frameworks
Veneering of zirconium oxide based copings / frameworks -

Device Description:

Composition:

The ceramics2in1 consists of following components: SiO2, ZrO2, Al2O3, B2O3, K2O, Na2O, SrO, CeO2, SnO2, ZnO, P205, CaO, Li2O, F and pigments. Despite differences in the chemical composition to the predicated device the ceramics2in1 does not show any unacceptable toxic or allergic potential and is considered to be highly biocompatible. According to the biocompatibility evaluation the following statement is valid: Due to the current standard of knowledge the ceramics2in1 dental porcelain system does not show unacceptable health risks arising for patients, applying technicians or dentists

Physical properties:

All components forming the final veneering have been evaluated on soludablity according to ISO 6872 and bond strength and flexural strength according to ISO 6872. The results are not significantly different to the predicate device and are all within the limits of the standards.

Conclusion:

The overall composition of the system, the technological characters, physical properties and indications of the ceramics2in1 are substantially equivalent to the predicate device.

Section 1
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Revision 1.1

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure with outstretched arms. The figure is composed of three curved lines that suggest movement and energy.

Public Health Service

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

MAY 2 5 2010

Mr. David Eiler Regulatory Affairs Manager Biodenta Swiss AG Tramstrasse 16 Berneck Switzerland 9442

Re: K100150

Trade/Device Name: Ceramics2in1 Regulation Number: 21CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 7, 2010 Received: May 10, 2010

Dear Mr. Eiler:

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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Page 2- Mr. David Eiler

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

h for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use

510(k) Number (if known): _ | | | |0015 0

Device Name: ceramics2in1

The dental ceramic ceramics2in1 is a low fusing dental ceramic sinter material for the production of crowns and bridges made of zirconium oxide or titanium based coping and frameworks.

Veneering of titanium copings / frameworks -
-Veneering of zirconium oxide based copings / frameworks

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Page 1 of 1

Kein Mally Sn M.SR

ivision Sign-Off) Jivision of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: K100156

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.