SR-ISOCETTE
Device Facts
| Record ID | K811665 |
|---|---|
| Device Name | SR-ISOCETTE |
| Applicant | J. Aderer, Inc. |
| Product Code | ELK · Dental |
| Decision Date | Jul 15, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3910 |
| Device Class | Class 1 |
Regulatory Classification
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.
