(37 days)
Designed for use on zirconia (zirconium oxide) in single tooth or bridge type restorations. Applications include tooth anterior and posterior locations.
The CERCON® CERAM EXPRESS Ceramic System consists of a dental ceramic veneering material developed for veneering zirconium oxide substructures for fixed prosthodontics devices that include both anterior and posterior crowns and bridges. The modified device is a glass/glass-ceramic mixture used to veneer zirconia substrates in a medium-pressure. lost-wax injection molding (pressing) process. The modified device consists of a translucent material and an opaque material.
This 510(k) K041707 submission focuses on a dental ceramic veneering material (CERCON® CERAM EXPRESS Ceramic System) and demonstrates substantial equivalence to a predicate device, Cercon® Ceram S Porcelains (K022796).
The provided text does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the methodology (sample size, expert qualifications, adjudication, etc.) of such a study.
Instead, the submission primarily focuses on:
- Device Description and Intended Use: CERCON® CERAM EXPRESS Ceramic System is a glass/glass-ceramic mixture for veneering zirconia substructures in fixed prosthodontics.
- Technological Characteristics: It's a modification of an existing device (Cercon® Ceram S Porcelains, K022796) with changes to formulation, material form, and processing.
- Basis for Substantial Equivalence: The manufacturer asserts substantial equivalence based on the prior use of components in legally marketed devices, similarity in formulations, and data regarding modifications. This implies that the modifications did not introduce new questions of safety or effectiveness.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided document.
It's important to understand that for materials like this, "performance" is often demonstrated through mechanical and biocompatibility testing (e.g., flexural strength, bond strength, cytotoxicity) rather than clinical studies with human readers or AI algorithms as would be relevant for diagnostic imaging devices. Such tests would typically compare the modified device's properties to the predicate device or established standards. However, the details of these tests are not present in the provided summary.
Here's what can be inferred or stated about what is NOT present:
- Table of Acceptance Criteria and Reported Device Performance: Not available in this document.
- Sample Size and Data Provenance (Test Set): Not applicable or not reported for the type of comparison made. There is no "test set" in the context of human readers or AI performance.
- Number of Experts and Qualifications (Ground Truth): Not applicable.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not conducted or reported. This device is a material, not a diagnostic tool requiring human reader interpretation or AI assistance in that sense.
- Standalone (Algorithm Only) Performance: Not applicable. There is no algorithm.
- Type of Ground Truth Used: Not applicable in the context of expert consensus, pathology, or outcomes data for a diagnostic algorithm.
- Sample Size for Training Set: Not applicable. There's no AI model being trained.
- How Ground Truth for Training Set was Established: Not applicable.
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510(k) SUMMARY
JUL 3 0 2004
NAME & ADDRESS:
DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 Telefax (717) 849-4343
CONTACT: P. Jeffery Lehn
DATE PREPARED: June 18, 2004
TRADE OR PROPRIETARY NAME: CERCON® CERAM EXPRESS Ceramic System
CLASSIFICATION NAME: Porcelain powder for clinical use (872.6660)
Cercon® Ceram S Porcelains (K022796) PREDICATE DEVICE:
DEVICE DESCRIPTION: The CERCON® CERAM EXPRESS Ceramic System consists of a dental ceramic veneering material developed for veneering zirconium oxide substructures for fixed prosthodontics devices that include both anterior and posterior crowns and bridges. The modified device is a glass/glass-ceramic mixture used to veneer zirconia substrates in a medium-pressure. lost-wax injection molding (pressing) process. The modified device consists of a translucent material and an opaque material.
INTENDED USE: Designed for use on zirconia (zirconium oxide) in single tooth or bridge type restorations. Applications include tooth anterior and posterior locations.
TECHNOLOGICAL CHARACTERISTICS: CERCON® CERAM EXPRESS Ceramic System represents a modification to Cercon® Ceram S Porcelains (K022796). Changes have been made to the device's formulation, material form, and processing technique.
All of the components found in CERCON® CERAM EXPRESS Ceramic System have been used in legally marketed devices.
We believe that the prior use of the components of CERCON® CERAM EXPRESS Ceramic System in legally marketed devices, the similarity in the formulations between the modified and the marketed device, and the data provided regarding the modifications to the marketed device support the safety and effectiveness of CERCON® CERAM EXPRESS Ceramic System for the intended use.
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Image /page/1/Picture/1 description: The image is a seal with the words "DEPARTMENT OF HEALTH & HUMAN JUSTICE - USA" arranged in a circle around a stylized image of an eagle. The eagle is facing right and has three curved lines representing its wings and body. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2004
Mr. P. Jeffery Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY, International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404
Re: K041707
Trade/Device Name: CERCON® CERAM EXPRESS Ceramic System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: June 18, 2004 Received: June 23, 2004
Dear Mr. Lehn:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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. Lehn
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Chi-Lin, Ph.D.
Chiu Lin, Ph.D. 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 STATEMENT
(As Required by 21 CFR 807.87(e)
Ko41707 510(K) Number (if known):
Device Name: CERCON® CERAM EXPRESS Ceramic System
Indications for Use:
Designed for use on zirconia (zirconium oxide) in single tooth or bridge type restorations. Applications include tooth anterior and posterior locations.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ken Morley
(Divisio
Divisio of Anesthesony Genera, nospital,
Infection Control Dental Devices
510(k) Nuribe K041707
ー
§ 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.