(71 days)
Not Found
No
The summary describes preformed plastic denture teeth made of PMMA and other acrylic resins. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of these technologies. The testing described is based on physical and biocompatibility standards for dental materials.
No
The device is described as "Teeth for the fabrication of dentures" and "A preformed plastic denture tooth," which functions as a replacement for natural teeth, not for treating a disease or condition. The "Summary of Performance Studies" states, "The device is safe and effective to be used as denture teeth."
No
The device description indicates that these are preformed plastic denture teeth used for the fabrication of dentures, not for diagnosing any condition.
No
The device description clearly states it is a "preformed plastic denture tooth" composed of Polymethyl Methacrylate and other acrylic resins, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of dentures, which are prosthetic devices used to replace missing teeth. This is a mechanical and structural application, not a diagnostic one.
- Device Description: The description details the material composition and manufacturing process of preformed plastic teeth. There is no mention of any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition
- Use in a laboratory setting for diagnostic purposes
The device is clearly intended for use as a component in a dental prosthesis, which is a medical device but not an IVD.
N/A
Intended Use / 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.
Product codes
ELM
Device 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K033628, K792245, K915276, K060507, Kf130588, K033628, K022299, K022300, K061337
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3590 Preformed plastic denture tooth.
(a)
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.(b)
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.
0
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.
1
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.
2
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.
3
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
4
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: