(71 days)
Not Found
No
The summary describes preformed plastic teeth made of standard dental materials and does not mention any AI/ML components or functionalities.
No
The device description indicates that Artegral and Polystar Selection are preformed plastic teeth used in dentures, and their intended use is as teeth in dentures. This describes a prosthetic device, not a therapeutic device.
No
Explanation: The device is described as preformed plastic teeth intended for use in dentures. Its function is to replace teeth structurally, not to diagnose medical conditions or diseases.
No
The device is described as preformed plastic teeth composed of polymethylmethacrylate and co-polymers, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "intended for use as teeth in dentures." This is a prosthetic device used in the body, not a device used in vitro (outside the body) to examine specimens from the body for diagnostic purposes.
- Device Description: The description details the materials used to construct the teeth, which are physical components for a denture.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, Artegral and Polystar® Selection are medical devices, but they fall under a different category than IVDs. They are considered prosthetic devices.
N/A
Intended Use / Indications for Use
Artegral, and Polystar® Selection are intended for use as teeth in dentures.
Artegral, and Polystar® Selection preformed plastic teeth are prefabricated devices composed of polymethylmethacrylate and cross-linking co-polymers of methacrylic acid (IPN) intended for use as teeth in dentures.
Product codes
ELM
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance and safety testing activities were conducted against recognized standards to establish the reliability characteristics of the new devices. Testing involved bench studies, and biocompatibility tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
S :ction 3.0 510(k) Summary
| Submitted by: | Merz Dental GmbH
Eetzweg 20
D-24321 Luetjenburg
Germany
Phone: + 49.4381.4030
Fax: + 49.4381.403100 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | This summary was prepared on February 20, 2003. |
| Device name: | Artegral, and Polystar Selection |
| Common Name: | Preformed Plastic Denture Teeth |
| Classification Name: | Denture, Plastic, Teeth: 21 CFR §872.3590, ProCode 76 ELM |
| Predicate Devices: | Dental Vipi Ltda: Acry Pan, Vipi Dent Plus, Biolux, Biolux V,
New Dent, Dentoluxx, Vipi Dent N.H. and Vipi Dent V
Preformed Plastic Denture Teeth (K022300). |
| Modifications: | Differences in available size, shape, and color. |
| Intended Use: | Artegral, and Polystar® Selection are intended for use as teeth
in dentures. |
| Technological
Characteristics: | Comparable chemical composition as the predicate. |
| Testing: | Performance and safety testing activities were conducted
against recognized standards to establish the reliability
characteristics of the new devices. Testing involved bench
studies, and biocompatibility tests. |
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal are three stylized human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2003
Merz Dental GmbH C/O Mr. James Delaney EXPERTech Associates, Incorporated 100 Main Street, Suite 120 Concord, Massachusetts 01742
Re: K030588
Trade/Device Name: Artegral and Polystar Selection® Performed Plastic Denture Teeth Regulation Number: 21 CFR 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: February 21, 2003 Received: February 25, 2003
Dear Mr. Delaney:
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. Delaney
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 vour 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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Susie Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
51 J(k) Number (if known)
K030588 ______________________________________________________________________________________________________________________________________________________________________
Device Name
Merz Dental GmbH Artegral, and Polystar® Selection preformed plastic denture teeth
Indications for Use Artegral, and Polystar® Selection preformed plastic teeth are prefabricated devices composed of polymethylmethacrylate and cross-linking co-polymers of methacrylic acid (IPN) intended for use as teeth in dentures.