(89 days)
CEREC Blocs C In are indicated for the fabrication of veneers and of crowns in anterior teeth and in premolars that have not been endodontically treated, using the Sirona CAD/CAM system.
CEREC Blocs C In is an industrially manufactured, silicate glass ceramic block used to produce crowns and veneer. The block consists of an inlying, highly-chromatic dentine core and an overlying translucent enamel layer. It is grinded to custom made dental restorations using Sirona CAD/CAM systems. The block is initially manufactured in a sintered state; then, is individually processed to specification. One end plane of a block is mounted to a metal carrier that is inserted in the spindle's clamping chuck of the grinding machine.
CEREC Blocs C In are available in several colors and additional bleach color. The dental restorations obtain their individual color appearance by stain and glaze firing.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study for the CEREC Blocs C In device:
Based on the provided 510(k) summary, the device is a dental material (porcelain powder) for fabricating restorations, not an AI/ML device. Therefore, many of the typical AI/ML study components (like sample size for test set, experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable.
The acceptance criteria provided are in relation to the physical and chemical properties of the material itself, and the "study" demonstrating compliance is non-clinical testing and comparison to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Properties | Acceptance Criteria (from predicate) / Measurement Standard | Reported Device Performance (CEREC Blocs C In) |
|---|---|---|
| Coefficient of thermal expansion CTE (20 – 500 °C) | Not explicitly stated as acceptance criteria, but for comparison to predicate. | (9.3 ± 0.3) 10^-6 K^-1 |
| Density | Not explicitly stated as acceptance criteria, but for comparison to predicate. | 2.36 g/cm³ |
| Bending strength (ISO 6872) | Meets ISO 6872: 2008 standard (for ceramic materials). | 123 ± 18 MPa |
| Transformation range | Not explicitly stated as acceptance criteria, but for comparison to predicate. | 620 ± 20 °C |
| Biocompatibility | Complies with ISO 10993-1: 2009 | Material is biocompatible |
| Chemical Properties (e.g., SiO2, Al2O3, Na2O, K2O, B2O3) | Similar to predicate device (Wieland Dental + Technik's Press X Zr). | Matches specified percentages. |
| Physical Properties (general) | Similar to predicate devices (Vitablocs®, Vitablocs®). | "Physical properties are similar for all devices." |
| Material compliance | Meets ISO 6872: 2008, "Dentistry -- Ceramic materials". | The device is stated to meet this standard. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. Standard material testing usually involves a sufficient number of samples to achieve statistical significance for each property test, but the exact number isn't detailed in the summary.
- Data Provenance: The tests are non-clinical, likely lab-based measurements performed by the manufacturer, Sirona Dental Systems GmbH, in Germany. The data is prospective in the sense that the tests were performed on newly manufactured blocks to characterize their properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a material, not a diagnostic or AI/ML device that requires human expert ground truth. The "ground truth" for material properties is established by recognized international standards (e.g., ISO 6872, ISO 10993-1) and objective physical and chemical testing.
4. Adjudication method for the test set
Not applicable. This is a material properties test, not a subjective assessment requiring adjudication.
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 not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The ground truth for the physical and chemical properties of the CEREC Blocs C In is based on:
- International Standards: Specifically, ISO 6872: 2008 ("Dentistry -- Ceramic materials") for bending strength and overall ceramic material compliance, and ISO 10993-1: 2009 for biocompatibility.
- Predicate Device Characteristics: Comparison to the known characteristics and performance of the legally marketed predicate devices (Vita's Vitablocs® and Wieland Dental + Technik's Press X Zr) to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device. The "ground truth" for the material's development would be established through principles of material science, engineering, and manufacturing processes aimed at achieving desired physical and chemical properties and clinical performance.
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510(k) Summary
for
MAR 20 2013
Sirona Dental Systems
CEREC Blocs C In
1 Sponsor Sirona Dental Systems GmbH Fabrikstrasse 31
D-64625 Bensheim
Germany
Contact Person: Fritz Kolle
Telephone: +49 6251 16 3294
Date Prepared: December 20, 2012
2 Device Name
Proprietary Name: CEREC Blocs C In
Common/Usual Name: Powder, Porcelain
Classification Name: Porcelain powder for clinical use
3 Device Classification
21 CFR 872.6660, Product Code EIH
Predicate Devices 4
Vita's Vitablocs® (K090644) and Wieland Dental + Technik's Press X Zr (K070772)
Sirona Dental 510(k) Summary
December 20, 2012
Page 1 of 4
CEREC Blocs C In
APPENDIX G
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5 Intended Use
Fabrication of Dental restorations using Sirona Dental CAD/CAM System.
Indications for Use б
CEREC Blocs C In are indicated for the production of crowns and veneers using Sirona CAD/CAM system.
7 Device Description
CEREC Blocs C In is an industrially manufactured, silicate glass ceramic block used to produce crowns and veneer. The block consists of an inlying, highly-chromatic dentine core and an overlying translucent enamel layer. It is grinded to custom made dental restorations using Sirona CAD/CAM systems. The block is initially manufactured in a sintered state; then, is individually processed to specification. One end plane of a block is mounted to a metal carrier that is inserted in the spindle's clamping chuck of the grinding machine.
CEREC Blocs C In are available in several colors and additional bleach color. The dental restorations obtain their individual color appearance by stain and glaze firing.
8 Scientific Concept
The underlying scientific concept is
- · Processing dental restorations by Sirona Dental CAD/CAM System
- · Restorations are grinded from an CEREC C In by a Sirona CAM machine
Physical and Performance Characteristics 9
9.1 Design
The design of the CEREC Blocs C In is described in section 7, Device Description.
9.2 Material Used
CEREC C In ceramics constitute blocks comprised of silicate glass ceramic. One end plane of a block is mounted to a metal carrier that is inserted in the spindle's
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clamping chuck of the grinding machine. The material is biocompatible according to ISO 10993-1: 2009, "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process".
9.3 Physical Properties
Final technical data of CEREC C In:
| Properties | Value |
|---|---|
| Coefficient of thermal expansion CTE(20 – 500 °C) | $(9.3 \pm 0.3)10^{-6}$ K -1 |
| Density | 2.36 g/cm³ |
| Bending strength (ISO 6872) | 123 ± 18 MPa |
| Transformation range | 620 ± 20 °C |
Chemical Properties 9.4
| Component | % of Total Weight |
|---|---|
| SiO2 | 55 - 65 |
| Al2O3 | 17 - 24 |
| Na2O | 5 - 9 |
| K2O | 7 - 11 |
| B2O3 | 0-2 |
Oxides, contained in very low concentrations and used e.g. for coloring, are not specified here.
Sirona Dental 510(k) Summary
CEREC Blocs C In
APPENDIX G
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10 Summary of the technological characteristics
Sirona CEREC C In and Wieland Dental + Technik's Press X Zr are made of silicate glass ceramic. Chemical properties are similar. Sirona CEREC C In and Vita's Vitablocs® are block shaped. All devices meet the ISO 6872: 2008, "Dentistry --Ceramic materials". Physical properties are similar for all devices.
11 Nonclinical Testing
Bending strength tests have been performed.
12 Clinical Testing
Clinical tests have not been performed.
13 Conclusion
Based on the overall comparison of indications for use, contra-indications, material properties and processing/fabrication, Sirona Dental Systems believes that the CEREC blocs C In are substantially equivalent to Vita`s Vitablocs® (K090644) and Wieland Dental + Technik's Press X Zr (K070772).
Sirona Dental 510(k) Summary
December 20, 2012
CEREC Blocs C In
APPENDIX G
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2013
Mr. Fritz Kolle Sirona Dental Systems GmbH Fabrikstrasse 31 Bensheim, Germany D-64625
Re: K123952
Trade/Device Name: CEREC Blocs C In Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 20, 2012 Received: December 21, 2012
Dear Mr. Kolle:
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. Kolle
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 devicerelated 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,
Image /page/5/Picture/7 description: The image shows the name "Kwame O. Ulmer" with the letters "KO" in a stylized font. The word "for" is written in a smaller, simpler font to the right of the name. The name is likely associated with a campaign or organization, given the presence of the word "for."
Anthony D. Watson, B.S., M.S., M.B.A. 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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123952 510(k) Number (if known):
Device Name: _ CEREC Blocs C In
Indications for Use:
CEREC blocs C In are indicated for the fabrication of veneers and of crowns in anterior teeth and in premolars that have not been endodontically treated, using the Sirona CAD/CAM system.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary, S. Runner -S 013:03.19 005 PM ( E 3:53:46 -04'00'
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Sirona Dental Systems 510(k) CEREC C In
December 20, 2012
Page v
§ 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.