PRIMODENT ACRYLIC TEETH
Device Facts
| Record ID | K926070 |
|---|---|
| Device Name | PRIMODENT ACRYLIC TEETH |
| Applicant | I.T.C. Ent. |
| Product Code | ELM · Dental |
| Decision Date | Feb 17, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3590 |
| Device Class | Class 2 |
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.
