WIEDENT ESTETIC

K061337 · Xpdent Corp · ELM · Jun 7, 2006 · Dental

Device Facts

• Record ID: K061337
• Device Name: WIEDENT ESTETIC
• Applicant: Xpdent Corp
• Product Code: ELM · Dental
• Decision Date: Jun 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3590
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Acrylic teeth to be used for construction of full and partial dentures by a dental professional. Dentures are removable, not implanted in patients' mouths.

Device Story

Wiedent Estetic Teeth are preformed acrylic denture teeth used by dental professionals to fabricate removable full or partial dentures. The device serves as the prosthetic component for tooth replacement in patients. The teeth are manually processed and integrated into denture bases by dental technicians or dentists in a laboratory or clinical setting. The device provides a functional and aesthetic solution for patients requiring removable dental prosthetics.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Acrylic resin material; preformed denture tooth geometry; intended for integration into removable dental prosthetics; non-implantable; Class II device.

Indications for Use

Indicated for use by dental professionals in the construction of removable full and partial dentures for patients requiring prosthetic tooth replacement.

Regulatory Classification

Identification

A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carmen Perez Account Manager XPdent Corporation 12145 S.W. 131st Avenue Miami, FL 33186

## JUN -7 2006

Re: K061337

Trade/Device Name: Wiedent Esthetic Teeth Regulation Number: 21 CFR 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: May 10, 2006 Received: May 12, 2006

Dear Ms. Perez:

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. Carmen Perez

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,

Susan Vunno
Chin S. Lin, Ph.D.

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):

K061337

Device Name:

Wiedent Estetic Teeth

Indications For Use:

Acrylic teeth to be used for construction of full and partial dentures by a dental professional. Dentures are removable, not implanted in patients' mouths.

Prescription Use (Part 21 CFR 801 Subpart D)

(() Number

..

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Purr

Sin Sign-Off) on of Anesthesiology, General Hospital. Clien Control, Dental Devices

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