VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40

K052130 · Vident · EIH · Aug 15, 2005 · Dental

Device Facts

• Record ID: K052130
• Device Name: VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40
• Applicant: Vident
• Product Code: EIH · Dental
• Decision Date: Aug 15, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Vita In-Ceram® 2000 AL Cubes are ceramic blocks used as substructures for porcelain-fused-to-ceramic dental restorations. Dental professionals use CAD/CAM systems (Cerec 2, Cerec 3, or InLab) to machine the cubes into specific crown or bridge substructures. The resulting substructure provides the structural framework for the final restoration. The device is intended for professional use in a dental laboratory or clinical setting to restore patient dentition.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ceramic material (alumina-based) supplied as pre-formed cubes for CAD/CAM machining. Designed for use with Cerec 2, Cerec 3, and InLab systems. Class II device (21 CFR 872.6660).

Indications for Use

Indicated for dental patients requiring single unit anterior or posterior crowns or 3-unit anterior bridges. For use by dental professionals (DDS/DMD) only.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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)

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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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