ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V

K022300 · Dental Vipi Ltda · ELM · Oct 3, 2002 · Dental

Device Facts

• Record ID: K022300
• Device Name: ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V
• Applicant: Dental Vipi Ltda
• Product Code: ELM · Dental
• Decision Date: Oct 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3590
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H. and Vipi Dent V Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.

Device Story

Preformed plastic denture teeth (Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H., Vipi Dent V) composed of methyl methacrylate; used by dental professionals to fabricate complete or partial dentures; device serves as functional and aesthetic replacement for missing natural teeth; integrated into denture base during laboratory processing; provides patient with restored masticatory function and oral aesthetics.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Methyl methacrylate. Form factor: Preformed plastic teeth. Class I device. No software or electronic components.

Indications for Use

Indicated for use as replacement teeth in dentures for patients requiring prosthetic dental restoration.

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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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 0 3 2002

Dental Vipi Ltda C/O Mr. Kevin Walls Principal Consultant Regulatory Insight, Incorporated 13 Red Fox Lane Littleton, Colorado 80127

Re: K022300

Trade/Device Name: Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H. and Vipi Dent V Performed Plastic Denture Teeth Regulation Number: 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: I Product Code: 76 ELM Dated: July 15, 2002 Received: July 16, 2002

Dear Mr. Walls:

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 – Mr. Walls

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 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,

Timo Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## 510(k) Number (if known):

Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Device Name: Vipi Dent N.H. and Vipi Dent V Preformed Plastic Denture Teeth

Indications for Use: Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H. and Vipi Dent V Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.

PLE: SE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Tansey

(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use × (Per 21 CFR 801.109)