PREMIUM
Device Facts
| Record ID | K011130 |
|---|---|
| Device Name | PREMIUM |
| Applicant | Heraeus Kulzer, Inc. |
| Product Code | ELM · Dental |
| Decision Date | Jul 5, 2001 |
| 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.
