Retractor, All Types
FDA product code EIG · Class I (low risk) · 21 CFR 872.4565 · Dental
8510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971284 | OpaldamEIG · Traditional | Ultradent Products, Inc. | 06/03/1997SE |
| K854711 | Fibrelight Illuminating Oral RetractorsEIG · Traditional | Downs Surgical , Ltd. | 02/25/1986SE |
| K832366 | Zoller Burned Lip ConformerEIG · Traditional | Universal Prosthetics, Inc. | 09/26/1983SE |
| K821784 | Beach Gingival Retraction Instr. Type BEIG · Traditional | Pacific Dental Corp. | 07/06/1982SE |
| K771973 | GingitractEIG · Traditional | Den-Mat Corp. | 11/07/1977SE |
| K771399 | Lip & Cheek RetractorEIG · Traditional | L.D. Caulk Co. | 08/26/1977SE |
| K761024 | Racestyptine RingsEIG · Traditional | Septodont, Inc. | 11/19/1976SE |
| K760657 | Racestyptine CordEIG · Traditional | Septodont, Inc. | 09/27/1976SE |