VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310

K070991 · Vita · EBG · Jun 1, 2007 · Dental

Device Facts

• Record ID: K070991
• Device Name: VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310
• Applicant: Vita
• Product Code: EBG · Dental
• Decision Date: Jun 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CAD-Temp is used for the fabrication of multi-unit, full or partial anatomical long term temporary bridge restorations with up to 2 pontics using the inLab or CEREC systems of Sirona. The bridge block can also be used for temporary crowns. The Vita CAD-Temp acrylic polymer blocs are available in the four shades 0M1T, 2M2T, 3M2T, and 4M2T and in the size CT-40 (15.5 x 19 x 39 mm).

Device Story

Vita CAD-Temp is an acrylic polymer block used for dental restorations. It serves as raw material for CAD/CAM milling systems (Sirona inLab or CEREC). Dentists or dental technicians use these systems to design and mill full or partial anatomical temporary crowns and bridges. The device is intended for long-term temporary use. It provides a restorative solution for patients requiring temporary tooth replacement during the fabrication of permanent prosthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Acrylic polymer. Form factor: Pre-fabricated blocks (size CT-40: 15.5 x 19 x 39 mm). Intended for use with CAD/CAM milling systems. No electronic or software components integral to the block itself.

Indications for Use

Indicated for fabrication of long-term temporary crowns and multi-unit bridges (up to 2 pontics) using Sirona inLab or CEREC systems. For prescription use only.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2007

Ms. Elizabeth Wolfsen Regulatory Affairs Specialist VIDENT 3150 East Birch Street Brea, California 92821

Re: K070991

R070991
Trade/Device Name: Vita CAD-Temp for inLab® Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: April 03, 2007 Received: April 09, 2007

Dear Ms. Wolfsen:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(K) prematics is substant (for the indications for the indications for referenced above and have determined the devices marketed in interstate commence
use stated in the enclosure) to legally market devices marketed in interstate on to devices t use stated in the enclosure) to legally hiar Recon present Food Device Amendments, or to devices that pror to May 28, 1976, ure enactinent cate of the Federal Food. Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Features (RMA). You may have been reciassified in accordance with the provisions of the Act. The next Act (Act) that do not require approval of a prematiconspisions of the Act. The general therefore, market the device, subject to the general on your cegastration, listing of devices, good
controls provisions of the Act include requirements for annualize and adu controls provisions of the Net metade requiritions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (See above) into elections affecting your device can be
may be subject to such additional controls and 1904 - In oddition, FDA may publish may be subject to such additional controls. "Internet and to 898. In addition, FDA may publish found in the Code on the concerning your device in the Federal Register.

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Page 2 - Ms. Elizabeth Wolfsen

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Sugitte Y. Michine Ond

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): K070991

Vita CAD-Temp for inLab® Device Name:

## Indications For Use:

CAD-Temp is used for the fabrication of multi-unit, full or partial anatomical long term temporary bridge restorations with up to 2 pontics using the inLab or CEREC systems of Sirona. The bridge block can also be used for temporary crowns. The Vita CAD-Temp acrylic polymer blocs are available in the four shades 0M1T, 2M2T, 3M2T, and 4M2T and in the size CT-40 (15.5 x 19 x 39 mm).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Hai Ruby for KSR*
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ion of Anesthesiology, General Hospital, Section 4 Page 1 of 1
ion Control, Dental Devices
(k) Number: K070991