Product code EIG
- Device name
- Retractor, All Types
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4565
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971284 | OPALDAM | Ultradent Products, Inc. | 1997-06-03 |
| K854711 | FIBRELIGHT ILLUMINATING ORAL RETRACTORS | Downs Surgical , Ltd. | 1986-02-25 |
| K832366 | ZOLLER BURNED LIP CONFORMER | Universal Prosthetics, Inc. | 1983-09-26 |
| K821784 | BEACH GINGIVAL RETRACTION INSTR. TYPE B | Pacific Dental Corp. | 1982-07-06 |
| K771973 | GINGITRACT | Den-Mat Corp. | 1977-11-07 |
| K771399 | LIP & CHEEK RETRACTOR | L.D. Caulk Co. | 1977-08-26 |
| K761024 | RACESTYPTINE RINGS | Septodont, Inc. | 1976-11-19 |
| K760657 | RACESTYPTINE CORD | Septodont, Inc. | 1976-09-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00883205029119 | OpalDam | ULTRADENT PRODUCTS, INC. | 2026-08-22 |
| 00883205029102 | OpalDam | ULTRADENT PRODUCTS, INC. | 2026-08-22 |
| 00883205029157 | OpalDam | ULTRADENT PRODUCTS, INC. | 2026-08-22 |
| 00883205029140 | OpalDam | ULTRADENT PRODUCTS, INC. | 2026-08-22 |
| 00883205029133 | OpalDam | ULTRADENT PRODUCTS, INC. | 2026-08-22 |
| 00883205029126 | OpalDam | ULTRADENT PRODUCTS, INC. | 2026-08-22 |
| 00190776426491 | Millennium | Avalign Technologies, Inc. | 2026-08-18 |
| 00190776426514 | Millennium | Avalign Technologies, Inc. | 2026-08-18 |
| 00190776426521 | Millennium | Avalign Technologies, Inc. | 2026-08-18 |
| 00190776426538 | Millennium | Avalign Technologies, Inc. | 2026-08-18 |
| G879OBG30100 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G879LB4013 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G879LB35140 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G879LB30100 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G879KLB40110 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G879KLB36110 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G879KLB25060 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G8791062480 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G8791062470 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G8791048560 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G879103185S0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G879103185M0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G879103185L0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G8791031830 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G8791031820 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G8791030380 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G8791030260 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G8791030250 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G879103024L0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |
| G8791030240 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-15 |