(126 days)
Not Found
No
The summary describes a dental ceramic material and its intended use in prosthetic dentistry, with no mention of AI or ML technology.
No
The device is a dental ceramic material used for manufacturing crowns and bridges, not directly for treating or diagnosing a medical condition.
No
The device is a dental ceramic material used for creating crowns and bridges, not for diagnosing medical conditions.
No
The device description clearly states it is a "porcelain powder system" and "ceramic materials," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the production of dental crowns and bridges by veneering zirconium oxide or titanium frameworks. This is a restorative dental procedure, not a diagnostic test performed on biological samples.
- Device Description: The device is a porcelain powder system used in prosthetic dentistry to create a hard prosthesis. This aligns with the creation of a physical dental restoration, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device is clearly intended for the fabrication of dental prosthetics, which falls under the category of dental devices rather than in vitro diagnostics.
N/A
Intended Use / 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 -
Product codes (comma separated list FDA assigned to the subject device)
EIH
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The overall composition of the system, the technological characters, physical properties and indications of the ceramics2in1 are substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
ﺑ
MAY 2 5 .
510(k) Summary
100150
| owner's name: | Biodenta Swiss AG |
|---|---|
| address: | Tramstrasse 16 |
| 9442 Berneck | |
| Switzerland | |
| 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 your | |
| firm is claiming equivalence | The following predicate device is used to show |
| the substantial equivalence concerning the | |
| general design of the ceramics2in1 system | |
| company: | Dentaurum, Inc. |
| device: | Triceram |
| 510(k) No.: | K011428 |
1
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.
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.
3
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
4
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