CERAMICS2IN1

K100150 · Biodenta Swiss AG · EIH · May 25, 2010 · Dental

Device Facts

• Record ID: K100150
• Device Name: CERAMICS2IN1
• Applicant: Biodenta Swiss AG
• Product Code: EIH · Dental
• Decision Date: May 25, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

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

Device Story

Porcelain powder system for dental prosthetics; used to veneer titanium or zirconium oxide copings/frameworks. Technician applies powder to framework; heated in dental oven to create hard, glass-like finish. Components include shoulder margin, opaque, dentin, incisal, effect, opal, gingiva, stains, shades, glaze, and liquids. Used in dental laboratories by technicians to fabricate crowns and bridges. Final output is a finished dental prosthesis; provides aesthetic and functional restoration for patients.

Clinical Evidence

Bench testing only. Evaluated solubility, bond strength, and flexural strength according to ISO 6872. Results showed no significant difference compared to the predicate device and remained within standard limits. Biocompatibility evaluation confirmed no unacceptable health risks.

Technological Characteristics

Low fusing dental ceramic powder. Composition: SiO2, ZrO2, Al2O3, B2O3, K2O, Na2O, SrO, CeO2, SnO2, ZnO, P205, CaO, Li2O, F, and pigments. Physical properties tested per ISO 6872. Thermal processing (oven heating) required for sintering. No software or electronic components.

Indications for Use

Indicated for the veneering of titanium or zirconium oxide-based dental copings and frameworks in the production of crowns and bridges.

Regulatory Classification

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.

Predicate Devices

• Triceram (K011428)

Submission Summary (Full Text)

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510(k) Summary

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# MAY 2 5 .

510(k) Summary

100150

| owner's name: | Biodenta Swiss AG |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| address: | Tramstrasse 16<br>9442 Berneck<br>Switzerland |
| phone: | [phone] |
| fax numbers: | [phone] |
| 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 your<br>firm is claiming equivalence | The following predicate device is used to show<br>the substantial equivalence concerning the<br>general 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:

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.

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

#### 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.

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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 [phone] or [phone] 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.

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

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