TETRIC EVOCERAM

K042819 · Ivoclar Vivadent, Inc. · EBF · Nov 9, 2004 · Dental

Device Facts

• Record ID: K042819
• Device Name: TETRIC EVOCERAM
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: EBF · Dental
• Decision Date: Nov 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Anterior restorations (Class III, IV) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Restorations in the posterior region (Class I and II) Veneering of discolored anterior teeth Splinting of mobile teeth Repair of composite and ceramic veneers

Device Story

Tetric EvoCeram is a light-cured, radiopaque, nano-optimized restorative composite resin. Used by dental professionals in clinical settings for direct restorative procedures. Material is placed into prepared tooth cavities or used for veneering/splinting; cured via light activation to achieve structural hardening. Provides aesthetic and functional tooth restoration. Benefits include versatility across anterior and posterior regions and suitability for various defect types.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-cured, radiopaque, nano-optimized composite resin. Classified as tooth shade resin material (21 CFR 872.3690).

Indications for Use

Indicated for patients requiring dental restorations including Class I-V cavities, veneering of discolored anterior teeth, splinting of mobile teeth, and repair of composite or ceramic veneers.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of a bird-like figure with three curved lines representing its wings or body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2004

Ms. Donna Marie Hartnett Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K042819

Trade/Device Name: TETRIC EVOCERAM Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: October 7, 2004 Received: October 13, 2004

Dear Ms. Hartnett:

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 vour 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); 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" (21CFR 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/dsma/dsmamain.html

Sincerely yours,

Chis

Chiu Lin, Ph.D. 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): Koul 2 8 l 9

Device Name: TETRIC EVOCERAM Indications For Use:

## Intended Use:

Anterior restorations (Class III, IV) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Restorations in the posterior region (Class I and II) Veneering of discolored anterior teeth Splinting of mobile teeth Repair of composite and ceramic veneers

Susan Quinn

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

510(k) Number: K0612859

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

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

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

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