NEW OUTLINE

K023079 · Anaxdent GmbH · EBG · Oct 30, 2002 · Dental

Device Facts

• Record ID: K023079
• Device Name: NEW OUTLINE
• Applicant: Anaxdent GmbH
• Product Code: EBG · Dental
• Decision Date: Oct 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NEW OUTLINE is a resin used by dentists and dental technicians to fabricate temporary crowns and bridges.

Device Story

New Outline is a dental resin material used by dentists and dental technicians to fabricate temporary crowns and bridges. The device serves as a restorative material for temporary dental applications. It is used in a clinical or laboratory setting to create provisional dental prosthetics. The device benefits patients by providing a temporary solution for crown and bridge needs during the interim period before permanent restoration placement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Temporary crown and bridge resin. Material properties and composition are consistent with standard dental resins used for temporary prosthetics.

Indications for Use

Indicated for use by dentists and dental technicians to fabricate temporary crowns and bridges.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Anaxdent GmbH C/O Ms. Dvorah Richman King & Spalding 1730 Pennsylvania Avenue, N.W. Washington, D.C. 20006

Re: K023079

Trade/Device Name: New Outline Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: August 27, 2002 Received: September 16, 2002

Dear Ms. Richman:

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.

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.

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Page 2 - Ms. Richman

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

Timothy A. Ulatowski 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 Statemen

510(k) Number (if known)

Device Name: NEW OUTLINE

Indications for Use:

NEW OUTLINE is a resin used by dentists and dental technicians to fabricate temporary crowns and bridges.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Quinn

(Optional Format 3-10-98)

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

510(k) Number: K023079

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