REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH
Device Facts
| Record ID | K070591 |
|---|---|
| Device Name | REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH |
| Applicant | Union Dental S.A./Unidesa.Odi |
| Product Code | ELM · Dental |
| Decision Date | May 11, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3590 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
It is intended for use as a tooth in a denture. These teeth are used for making full or partial dentures. The artificial resin teeth are mounted on an appliance made of dental acryli: resin. The appliance is made to fit the patients mouth and is a removable. It is not implanted.
Device Story
Preformed plastic denture teeth; composed of Polymethyl Methacrylate (PMMA) with acrylic resins, reticulant agents, and non-toxic pigments. Manufactured via polymerization to create layered enamel, dentine, and neck structures; finished by removing burrs and polishing. Used by dental professionals to fabricate removable full or partial dentures. Mounted on dental acrylic resin appliances to fit patient anatomy. Provides aesthetic and functional tooth replacement; non-implanted.
Clinical Evidence
Bench testing performed according to ISO 3336:1993 (Dentistry-Synthetic Polymer Teeth), which is equivalent to ISO ADA Specification No. 15:1999. Biocompatibility testing and clinical evaluation conducted per directive 93/42/EEC, Annex X, Option I.
Technological Characteristics
Material: Polymethyl Methacrylate (PMMA) with acrylic monomers, reticulant agents, and non-toxic pigments. Form factor: Preformed, multi-layered (enamel, dentine, neck) plastic teeth. Standards: ISO 3336:1993 / ISO ADA Specification No. 15:1999. Non-powered, mechanical prosthetic device.
Indications for Use
Indicated for use as artificial teeth in the fabrication of full or partial removable 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.
Predicate Devices
- Heraeus Kulzer Artic plastic teeth (K033628)
- Dentsply Int. teeth (K792245)
- Nobelpharma Usa,Inc. teeth (K915276)
- Yamhachi teeth (K060507)
- Artegral and polystar Selection teeth (Kf130588)
- Trilux, Z-tone, Acryrock teeth (K022299)
- Acry Pan, Vipi Dent Plus teeth (K022300)
- Wiedent Estetic teeth (K061337)
Submission Summary (Full Text)
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Paseo de la Estación, 4
28550 Tielmes (Madrid)
Tel. 91 873 76 30
Fax 91 874 64 90
Image /page/0/Picture/1 description: The image shows the logo for "unidesa". Below the word "unidesa" is the text "UNION DENTAL S.A.". The text is black and the background is white.
# *(Premarket Notification [510(k)] Number: K070591)
# 510(k) SUMMARY
MAY 1 ] 2007
### Submitter
Company name: Union Dental S.A./ Unidesa.Odi
Address: Paseo de la Estación, 4 28550 Tielmes Madrid. Spain
| Contact name: | José Luis Rodríguez |
|---------------|-------------------------|
| Telephone No. | 011-34-91-873-76-30 |
| Fax No. | 011-91-874-64-90 |
| e-mail: | unidesa@unidesa-odi.com |
Date of Summary: April 19th 2007
## Device Name
Classification name: preformed plastic teeth. I isted in Part 872- Dental Devices, Subpart D - Prosthetic Devices CFR Sec 872.3590
Proprietary name: Replica, Ortolux Top, Odipal. Odident, Vitacrilic, Natures Best
Common name: Denture teeth
## Predicate Devices
Heraeus Kulzer Artic plastic teeth (510K-K033628) Dentsply Int. teeth (510K-K792245) Nobelpharma Usa,Inc. teeth (510K-K915276) Yamhachi. teeth (510K-K060507) Artegral and polystar Selection teeth (510K-Kf130588) Artic teeth (510K-K033628) Trilux, Z-tone, Acryrock teeth (510K-K022299) Acry Pan, Vipi Dent Plus, teeth (510K-K022300) Wiedent Estetic teeth (510K-K061337)
The device is similar in size, shape. color, chemical composition and usage as the above products.
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Image /page/1/Picture/0 description: The image shows the logo for Unidesa, which is a dental company. The logo is in black and white, with the word "unidesa" in a bold, sans-serif font. Below the word "unidesa" is the phrase "UNION DENTAL, S.A." in a smaller, sans-serif font. To the right of the word "unidesa" is a graphic that is difficult to make out.
#### *(Premarket Notification [510(k)] Number: K070591) 510(k) SUMMARY (cont.)
#### Devices description
A preformed plastic denture tooth is a prefabricated device, composed of Polymethyl Methacrylate. The teeth are made up of several different acrylic resins that form the layers of enamel, dentine and neck, all of which are created using the polymerization of acrylic monomers, reticulant agents, resins and non-toxic pigments that form a unique composition, which with the union of the layers produces a compact whole that looks and behaves in a similar wav to real teeth.
Once the polymerization process has been carried out, the teeth are obtained and the next step is to remove any burrs and polish them. They are then mounted in the presentation units with the relevant product details (brand, model, colour and batch).
#### Intended use
It is intended for use as a tooth in a denture.
These teeth are used for making full or partial dentures. The artificial resin teeth are mounted on an appliance made of dental acryli: resin. The appliance is made to fit the patients mouth and is a removable. It is not implanted.
#### Technological characteristic and substantial equivalence
- The device has comparable chemical composition as the predicate devices.
- The device is similar in size, shape, color and usage as the above predicates devices.
The labeling includes the proprietary name, the shade which is comparable to competitiors such as Dentsply, Heraeus Kulzer, Vita Zahnfabrik, Nobelpharma, Heraeus Kulzer, Vipi, and Vierz Dental and a mold number which can be used to pick out the proper sized tooth for the patient.
#### Performance Testing
The device is tested according to ISO 3336:1993, Dentistry-Synthetic Polymer Teeth(Dental/ENT) which is similar to ISO ADA Specification No. 15:1999 Synthetic Resin Teeth and are Recognized Consensus Standards, Recognition List Number 007. Effective Date 05/31/2002
Testing also includes biocompatibility tests and clinical evaluation of health products in application of the directive 93/42/EEC. Annex X -. Option I.
Conclusions: The device is safe and effective to be used as denture teeth and is substantially equivalent to the predicated devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. José Luis Rodríguez Technical Director Union Dental S.A./ Unidesa. Odi Pasco de la Estación, 4 28550 Tielmes Madrid, Spain
MAY 1 1 2007
Re: K070591
Trade/Device Name: Replica, Ortolux Top, Odipal, Odilux, Odident Vitacrilic Natures Best. Dental Acrylic Teeth Regulation Number: 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: April 19, 2007 Received: April 23, 2007
Dear Mr. Rodríguez:
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. Rodríguez
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 (OS) 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runnes
Chiu Lin, Ph.D.
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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K070591
# Indications for Use
510(k) Number (if known): K070591)
Device Name:
Indications For Use:
Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Natures Best. Dental acrylic teeth.
Teeth for the fabrication of dentures
These teeth are used for making full or partial dentures. The These toon are mounted on an appliance made of dental acrylic resin. The appliance is made to fit the patients mouth and is a removable. It is not implanted.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) rion of Anesthesiology, General Hos Control, Dental De Page 1 of 1 __ Cik) Number:
