PZY · Additively Manufactured, Preformed, Resin Denture Tooth
Dental · 21 CFR 872.3590 · Class 2
Overview
| Product Code | PZY |
|---|---|
| Device Name | Additively Manufactured, Preformed, Resin Denture Tooth |
| Regulation | 21 CFR 872.3590 |
| Device Class | Class 2 |
| Review Panel | Dental |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K172398 | DENTCA DENTURE Teeth | Dentca, Inc. | Nov 22, 2017 | SESE |
Top Applicants
- Dentca, Inc. — 1 clearance
