21 CFR 872.3590 — Denture, Plastic, Teeth
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3590
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ELM | Denture, Plastic, Teeth | 2 | 55 | |
| PZY | Additively Manufactured, Preformed, Resin Denture Tooth | 2 | 1 |
Special Controls
ELM — Denture, Plastic, Teeth
*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.
eCFR
PZY — Additively Manufactured, Preformed, Resin Denture Tooth
*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.
eCFR
