ELK · Teeth, Artificial, Backing And Facing
Dental · 21 CFR 872.3910 · Class 1
Overview
| Product Code | ELK |
|---|---|
| Device Name | Teeth, Artificial, Backing And Facing |
| Regulation | 21 CFR 872.3910 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A backing and facing for an artificial tooth is a device intended for use in fabrication of a fixed or removable dental appliance, such as a crown or bridge. The backing, which is made of gold, is attached to the dental appliance and supports the tooth-colored facing, which is made of porcelain or plastic.
Classification Rationale
Class I (general 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K811665 | SR-ISOCETTE | J. Aderer, Inc. | Jul 15, 1981 | SESE |
| K760909 | THERMOMETER JARS AND CAPS | Plastics/Packaging | Dec 30, 1976 | SESE |
Top Applicants
- Plastics/Packaging — 1 clearance
- J. Aderer, Inc. — 1 clearance
