(105 days)
Cercon® ht is indicated in the anterior and posterior segments for:
- crowns
- telescopic primary crowns
- multi-unit bridges (with no more than two pontics between abutment crowns)
Cercon® ht can be used as a substructure (framework) which is then veneered with a dental veneering ceramic or can be used for full-contour application (without veneering) as well. In the case of telescopic primary crowns the substructure is not veneered.
Cercon ht is a ceramic composed of partially sintered yttria stabilized zirconia powder (Y-TZP). It is supplied to the dental laboratory as a blank and then processed in the dental-laboratory by machining and subsequent sintering to full density. It can be veneered with a dental veneering ceramic or can be used as anatomically shaped full-contour crown or bridge without veneering. It is designed for anterior and posterior locations as a substructure (framework) for single-tooth or bridge type restorations. It can also be used for the preparation of telescopic primary crowns.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Strength (Flexural Strength) | Similar to predicate device (Cercon Base) | "material has the same mechanical (flexural strength)... as the predicate device." |
| Chemical Stability (Solubility) | Similar to predicate device (Cercon Base) | "material has the same... chemical stability (solubility) as the predicate device." |
| Wear (of unveneered material itself) | Significantly lower abrasion compared to conventional veneering porcelain | "significantly lower compared to conventional veneering porcelain." |
| Wear (of antagonist teeth opposed to unveneered material) | Significantly lower abrasion compared to conventional veneering porcelain | "significantly lower compared to conventional veneering porcelain." |
| Fit of Large Bridges | Comparable to conventional metal cast frameworks | "comparable to conventional metal cast frameworks." |
| Fitting Accuracy of Telescopic Primary Crowns | Good fitting accuracy | "a good fitting accuracy... is achieved." |
| Surface Quality of Telescopic Primary Crowns | Good surface quality | "a good surface quality is achieved." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each non-clinical test (flexural strength, solubility, wear tests, fit tests, telescopic primary crown tests). The data provenance is not specified regarding country of origin; however, the tests were "Non-Clinical Performance Data" and "bench tests and professional evaluations" performed to demonstrate substantial equivalence to a predicate device. This suggests lab-based, retrospective testing rather than prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth. It mentions "professional evaluations" in the context of proving substantial equivalence but does not detail the methodology for these evaluations.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. Given the non-clinical nature of the tests, adjudication for human-based assessment as seen in clinical trials would not typically apply. The evaluation seems to rely on direct measurement and comparison to established benchmarks or predicate device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission relies solely on non-clinical performance data (mechanical and chemical property testing, wear tests, fit tests). The document explicitly states: "Clinical Performance Data. Not applicable."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the device described. Cercon ht is a physical dental material (zirconia ceramic) and not a software algorithm or AI device that would have "standalone" performance in the context of human-in-the-loop assessments.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests appears to be based on:
- Established physical and chemical properties: Standardized measurements for flexural strength and solubility.
- Comparative data against predicate device: Evaluating if Cercon ht performs "the same as" the predicate Cercon Base for mechanical and chemical properties.
- Benchmarks against conventional materials: Comparing wear to "conventional veneering porcelain" and fit to "conventional metal cast frameworks."
- Qualitative assessments of fit and surface quality: "good fitting accuracy and a good surface quality."
8. The Sample Size for the Training Set
This question is not applicable. Cercon ht is a physical dental material, not an AI/ML model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for a physical dental material.
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NOV - 9 2011
SECTION 5. 510(k) SUMMARY for Cercon ht
1. Submitter Information:
DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-849-4229 |
| Fax Number: | 717-849-4343 |
Date Prepared: November 8, 2011
-
- Device Name:
- . Proprietary Name: Cercon ht Classification Name: .
- Porcelain powder for clinical use
- CFR Number: 21CFR 872.6600
- Device Class: . II
- Product Code: EIH .
3. Predicate Device:
Cercon Base. K013230 and K051462
Description of Device: 4.
.
Cercon ht is a ceramic composed of partially sintered yttria stabilized zirconia powder (Y-TZP). It is supplied to the dental laboratory as a blank and then processed in the dental-laboratory by machining and subsequent sintering to full density. It can be veneered with a dental veneering ceramic or can be used as anatomically shaped full-contour crown or bridge without veneering. It is designed for anterior and posterior locations as a substructure (framework) for single-tooth or bridge type restorations. It can also be used for the preparation of telescopic primary crowns.
న్. Indications for Use:
Cercon® ht is indicated in the anterior and posterior segments for:
- crowns
- telescopic primary crowns ●
- multi-unit bridges (with no more than two pontics between abutment crowns) �
Cercon® ht can be used as a substructure (framework) which is then veneered with a dental veneering ceramic or can be used for full-contour application (without veneering) as well. In the case of telescopic primary crowns the substructure is not veneered.
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6. Description of Safety and Substantial Equivalence:
Technological Characteristics.
Cercon ht is an oxid-based ceramic composed of partially sintered yttria stabilized zirconia powder indicated for crown and bridge restorations. Cercon ht is a ceramic material according to ISO 6872 Type II / Class 6. The strength of this material is similar to that of dental alloys containing high gold. The components of Cercon ht have been used in the predicate devices and were found safe for dental use. The device has the same technological characteristics and composition as the predicate device. The main difference is the extended indication for use including bridges with a wider span, the use as full contour crown or bridge, the use for the preparation of telescopic primary crowns.
Non-Clinical Performance Data.
Measurements of the physical characteristics showed that the material has the same mechanical (flexural strength) and chemical stability (solubility) as the predicate device.
Wear Tests showed that the abrasion of the unveneered material itself and of the antagonist teeth opposed to the material is significantly lower compared to conventional veneering porcelain.
Test of the fit of large bridges showed that they are comparable to conventional metal cast frameworks.
Test of telescopic primary crowns showed that a good fitting accuracy and a good surface quality is achieved.
Clinical Performance Data. Not applicable.
Conclusion as to Substantial Equivalence
The chemical components used in the material of Cercon ht and its technological characteristics are the same as in the predicate device. The substantial equivalence of the indications for use has been proven by bench tests and professional evaluations.
- . The use of telescopic primary crowns has been evaluated with Cercon Base. As the physical properties of Cercon ht are similar to Cercon base (c.f. Section 12, Substantial Equivalent Discussion) it can be concluded that these results are valid for Cercon ht.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is likely part of a document header or title. The words are evenly spaced and the overall appearance is clean and professional.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Helen Lewis Director of Corporate Compliance & Regulatory Affairs Dentsply International, Incorporated Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404
NOV - 9 2011
Re: K112152
Trade/Device Name: Cercon ht Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 29, 2011 Received: September 30, 2011
Dear Ms. Lewis:
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 - Ms. Lewis
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/ReportalProblem/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,
Zh 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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SECTION 4. INDICATIONS FOR USE STATEMENT
K112152 510(k) Number (if known):
Device Name: Cercon ht
Indications for Use:
Cercon® ht is indicated in the anterior and posterior segments for:
- . crowns
- . telescopic primary crowns
- multi-unit bridges (with no more than two pontics between abutment crowns) .
Cercon® ht can be used as a substructure (framework) which is then veneered with a dental veneering ceramic or can be used for full-contour application (without veneering) as well. In the case of telescopic primary crowns, the substructure is not veneered.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Susan Rumsey
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112152
§ 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.