TELIO CAD

K093708 · Ivoclar Vivadent, Inc. · EBG · Mar 10, 2010 · Dental

Device Facts

• Record ID: K093708
• Device Name: TELIO CAD
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: EBG · Dental
• Decision Date: Mar 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended Use

For the fabrication of temporary crowns and bridges using the CAD/CAM technology until the permanent restoration can be delivered.

Device Story

TELIO CAD is a resin-based material used for the fabrication of temporary crowns and bridges. It is designed for use with CAD/CAM systems in a dental laboratory or clinical setting. The device is processed by milling the resin blocks into the desired temporary restoration shape based on digital dental impressions. The resulting temporary restoration is placed by a dental professional to protect the prepared tooth structure and maintain function/aesthetics until the final permanent restoration is completed. It benefits patients by providing a durable, interim solution during the restorative process.

Clinical Evidence

Bench testing only.

Technological Characteristics

Resin-based material for CAD/CAM milling. Form factor: blocks for milling. Intended for temporary crown and bridge fabrication. Class II device under 21 CFR 872.3770.

Indications for Use

Indicated for the fabrication of temporary crowns and bridges using CAD/CAM technology for patients requiring temporary restorations prior to permanent delivery.

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 and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the circumference of the circle.

Public Health Service

APR 2 9 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Donna Hartnett Director Quality Assurance Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

K093708 Re:

> Trade/Device Name: TELIO® CAD Regulation Number: 21CFR 872.3770 Regulation Name: Temporary Crown & Bridge Resin Regulatory Class: II Product Code: EBG Dated: January 28, 2010 Received: January 29, 2010

Dear Ms. Hartnett:

This letter corrects our substantially equivalent letter of March 10, 2010. 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 (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 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. Hartnett

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. 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): __ Kog 3708

Device Name: TELIO® CAD

Indications For Use:

For the fabrication of temporary crowns and bridges using the CAD/CAM technology until the permanent restoration can be delivered.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K093708