EIG — Retractor, All Types Class I
FDA product code EIG covers "Retractor, All Types", a Class I medical device regulated under 21 CFR 872.4565. Submissions are reviewed by the Dental panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EIG
- Device Class
- Class I
- Regulation Number
- 872.4565
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K971284 | Ultradent Products | OPALDAM | Jun 3, 1997 |
| K854711 | Downs Surgical | FIBRELIGHT ILLUMINATING ORAL RETRACTORS | Feb 25, 1986 |
| K832366 | Universal Prosthetics | ZOLLER BURNED LIP CONFORMER | Sep 26, 1983 |
| K821784 | Pacific Dental | BEACH GINGIVAL RETRACTION INSTR. TYPE B | Jul 6, 1982 |
| K771973 | Den-Mat | GINGITRACT | Nov 7, 1977 |
| K771399 | L.D. Caulk | LIP & CHEEK RETRACTOR | Aug 26, 1977 |
| K761024 | Septodont | RACESTYPTINE RINGS | Nov 19, 1976 |
| K760657 | Septodont | RACESTYPTINE CORD | Sep 27, 1976 |