21 CFR 872.3660 — Material, Impression
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3660
Identification
Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.
Classification Rationale
Class II (Special Controls).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ELW | Material, Impression | 2 | 402 | 3rd Party |
| SHI | Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter | 2 | 2 |
Special Controls
ELW — Material, Impression
*Classification.* Class II (Special Controls).
eCFR
SHI — Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
*Classification.* Class II (Special Controls).
eCFR
