(10 days)
In-Ceram® 2000 AL CUBES for inLab® are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges.
Substructures of AL Cubes for Cerec are machined using the Cerec 2, Cerec 3 and InLab cad/cam systems.
For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.
Vita In-Ceram® 2000 AL Cubes for inLab® are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges. Substructures of AL Cubes for Cerec are machined using the Cerec 2, Cerec 3 and InLab cad/cam systems.
The provided document is a 510(k) premarket notification letter from the FDA regarding "Vita In-Ceram® 2000 AL Cubes for inLab®". It states that the device is substantially equivalent to legally marketed predicate devices and outlines general control provisions and other regulations.
However, the document does not contain specific information about acceptance criteria, device performance metrics, sample sizes, expert qualifications, adjudication methods, or study designs (e.g., MRMC, standalone) as requested in your prompt. This type of information is typically found in the test reports, clinical study summaries, or performance sections of a 510(k) submission, but it is not detailed in the FDA's decision letter provided here.
Therefore, I cannot provide the requested table and information based on the given text. The document confirms the device's classification and allows it to be marketed, but it does not delve into the technical validation studies that led to that determination.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2005
Ms. Barbara J. Lewandowski Regulatory Affairs Specialist VIDENT Incorporated 3150 East Birch Street Brea, California 92821
Re: K052130
Trade/Device Name: Vita In-Ceram® 2000 AL Cubes for inLab® Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: July 27, 2005 Received: August 08, 2005
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.
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Page 2 - Ms. Barbara J. Lewandowski
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 (OS) 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html.
Sincerely yours,
Chiu S. Lin, PhD
Chiu S. Lin, PhD 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
510(k) Number (if known):
12052130
Device Name: Vita In-Ceram® 2000 AL CUBES for inLab® Indications for Use:
In-Ceram® 2000 AL CUBES for inLab® are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges.
Substructures of AL Cubes for Cerec are machined using the Cerec 2, Cerec 3 and InLab cad/cam systems.
For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.
Prescription Use × (21 CFR Part 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suva Runge
(Division Sian Off Division of Dental, Infection Control and General Hospital Devices
510(k) Number KO 52130
Prescription Use (Par. 21 CFR 801.109
OR
Over-The-Counter Use_
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§ 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.