(30 days)
Vita In-Ciram YZ® Cubes for Cerec® is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crowns and bridges. Sub tructures of YZ® Cubes for Cerec® are machined using the Cerec 2, Cerec 3 and InLat; systems.
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The provided document is a 510(k) premarket notification letter from the FDA regarding a dental device called "Vita In-Ceram YZ® Cubes for Cerec®." This document confirms the device's substantial equivalence to a predicate device and outlines general regulatory requirements.
However, the document does NOT contain any information about acceptance criteria, device performance studies, or the methodologies used to establish ground truth or training sets. Therefore, I cannot extract the requested information.
The 510(k) letter is a regulatory approval document, not a scientific study report. It states that the device is "substantially equivalent" to an existing legally marketed device, which typically means it has similar intended use, technological characteristics, and performs as safely and effectively as the predicate device. The detailed performance data and study methodologies you're asking for would usually be part of the submission package that led to this approval, but they are not included in this letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CT 0 9 2002
Ms. Barbara J. Lewandowski Regulatory Affairs Specialist Vident 3150 East Birch Street Brea, California 92821
Re: K022996
Trade/Device Name: Vita In-Cream YZ® Cubes for Cerec® Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: 76 EIH Dated: September 4, 2002 Received: September 9, 2002
Dear Ms. Lewandowski:
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 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.
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.
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Page 2 - Ms. Lewandowski
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
Patura Cuarite/for
Timothy A. Ulatowski 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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Koz2996
510 ( k) Number (if known):
Dev ce Nume: Vita In-Ceram YZ® Cubes for Cerec®
Indication: For Use:
Vita In-Ciram YZ® Cubes for Cerec® is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crowns and bridges. Sub tructures of YZ® Cubes for Cerec® are machined using the Cerec 2, Cerec 3 and InLat; systems.
(PI EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Pasner
(Di vision S: gn-Off) Di ision o Dental, Infection Control and General Hospital Devices
511 (k) Nun ber
Prescription Use (P :r 21 Cl R 801.109). OR
Over-The Counter Use
§ 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.