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 |
|---|---|---|---|
| 00858466005608 | POLYTRACTOR | DENTAMERICA, INC. | 2026-07-27 |
| 00190776405946 | Millennium | Avalign Technologies, Inc. | 2026-07-26 |
| 00190776405762 | Millennium | Avalign Technologies, Inc. | 2026-07-24 |
| 00190776405793 | Millennium | Avalign Technologies, Inc. | 2026-07-24 |
| 00190776403225 | Millennium | Avalign Technologies, Inc. | 2026-07-19 |
| 00190776395599 | Millennium | Avalign Technologies, Inc. | 2026-07-14 |
| 00840456223321 | JMU | JMU DENTAL, INC | 2026-07-07 |
| 00840456223338 | JMU | JMU DENTAL, INC | 2026-07-07 |
| 00840456223345 | JMU | JMU DENTAL, INC | 2026-07-07 |
| 00840456223352 | JMU | JMU DENTAL, INC | 2026-07-07 |
| 00840456200186 | JMU | JMU DENTAL, INC | 2026-07-06 |
| ESAM13991001 | STOMA® | Storz am Mark GmbH | 2022-11-07 |
| 00850004223345 | Candid Impression Kit | CANDID CARE CO. | 2021-10-07 |
| 00850004223987 | Candid Refinement Impression Kit | CANDID CARE CO. | 2021-03-31 |
| ESAM3990031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM3986021 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM14429021 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM14429011 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM14428001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM14427001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13988181 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| 00850004223024 | Candid Impression Kit | CANDID CARE CO. | 2020-07-20 |
| 00850004223147 | Candid Redo Impression Kit | CANDID CARE CO. | 2019-10-04 |
| 00850004223017 | Candid Impression Kit | CANDID CARE CO. | 2019-03-01 |
| 00850004223093 | Candid Redo Impression Kit | CANDID CARE CO. | 2019-03-01 |
| 00850004223086 | Candid Redo Impression Kit | CANDID CARE CO. | 2019-03-01 |
| 00850004223062 | Candid Redo Impression Kit | CANDID CARE CO. | 2019-03-01 |
| 00850004223055 | Candid Redo Impression Kit | CANDID CARE CO. | 2019-03-01 |
| 00850004223048 | Candid Redo Impression Kit | CANDID CARE CO. | 2019-03-01 |
| 00888118070685 | RETRACTOR | KLS-Martin L.P. | 2018-09-26 |