(63 days)
CARRARA PRESS SYSTEM is intended for the fabrication of ceramic crowns, inlays, onlays or venecrs. Fabrication of ceramic crowns, inlays, onlays, or veneers.
CARRARA PRESS SYSTEM is a porcelain system used for the fabrication of all-ceramic dental restorations. The system includes a core ceramic, press inlay ceramic, conditioner, and glaze.
The provided text is a 510(k) summary for the DENTSPLY International CARRARA PRESS SYSTEM, a porcelain system for dental restorations. It does not contain information about acceptance criteria, device performance metrics, or a study design. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on prior market history and material similarities.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for the training set was established.
The document explicitly states: "We believe that the prior use of the components of CARRARA PRESS SYSTEM in legally marketed devices, and the historical use of the device in Europe provide sufficient evidence of the safety and effectiveness of CARRARA PRESS SYSTEM for the indicated uses." This indicates that the regulatory approval was based on demonstrating equivalence rather than a new performance study with specific acceptance criteria.
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0 33667
510(k) SUMMARY JAN 2 3 2004
ENSPLY
NAME & ADDRESS:
DENTSPLY International
570 West College Avenue P.O. Box 872 York, PA 17405-0872 17171 845-7511 Fox 777 849-4762 www.dentsply.com
P. J. Lchn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
DATE PREPARED: November 19, 2003
CARRARA PRESS SYSTEM TRADE OR PROPRIETARY NAME:
Porcelain powder for clinical use (872.6660) CLASSIFICATION NAME:
Cergogold Pressable Ceramic K993897 PREDICATE DEVICES:
CARRARA PRESS SYSTEM is a porcelain system used for the DEVICE DESCRIPTION: fabrication of all-ceramic dental restorations. The system includes a core ceramic, press inlay ceramic, conditioner, and glaze,
INTENDED USE: CARRARA PRESS SYSTEM is intended for the fabrication of ceramic crowns, inlays, onlays or venecrs.
TECHNOLOGICAI, CHARACTERISTICS: All of the components found in CARRARA PRESS SYSTEM have been used in legally marketed devices.
This device has been on the European market since 2000 with over 100,000 Core units placed This device has been on the Barspearse of this marketing history and the similarities between the CARRARA PRESS SYSTEM and the predicate device, no further biocompatibility testing was necessary.
We believe that the prior use of the components of CARRARA PRESS SYSTEM in legally we boneve the provided, and the historical use of the historical use of the device in Europe marketty and effectiveness of CARRARA PRESS SYSTEM for the indicated uses.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and two curved lines representing its legs. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2004
Mr. P. Jeffery Lehn Director of Corporate Compliance & Regulatory Affairs DENTSPLY International Susuehanna Commerce Center 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re: K033667
Trade/Device Name: CARRARA Press System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinic Use Regulatory Class: II Product Code: EIH Dated: November19, 2003 Received: November 21, 2003
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 rcclassified 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 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. 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 vour 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) 594-4618. 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 vours,
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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Ko33667
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known):
CARRARA PRESS SYSTEM Device Name:
Indications for Use:
Fabrication of ceramic crowns, inlays, onlays, or veneers.
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrencc of CDRH, Office of Device Evaluation (ODE)
Prescription Use
ાર
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Susan Runyon
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number.
§ 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.