EIGClass I
Retractor, All Types
21 CFR 872.4565 / Dental
EIG is the FDA product code for Retractor, All Types, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- EIG
- Device name
- Retractor, All Types
- Regulation
- 21 CFR 872.4565
- Device class
- Class I
- Review panel
- Dental
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 8
- Ingested recalls
- 0
Clearances, product code EIG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 2 |
| 1982 | 1 |
| 1983 | 1 |
| 1986 | 1 |
| 1997 | 1 |
Applicants with the most clearances
Product code EIG| Applicant | Clearances |
|---|---|
| Septodont | 2 |
| Den-Mat Corp. | 1 |
| Downs Surgical, Ltd. | 1 |
| L.D. Caulk Co. | 1 |
| Pacific Dental Corp. | 1 |
| Ultradent Products Inc. | 1 |
| Universal Prosthetics, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- 3D Dental Desings and Development
- A. Schweickhardt GmbH & Co. KG
- A.handte Medizintechnik GmbH & Co. KG
- Accompany Surgical
- Acheron Instruments (Pvt.) Ltd.
- Acme Commercial Ways Ltd.
- Acme Enterprises
- Adler Instrument Company
- Aesculap Inc
- Align Technology de Costa Rica S.R.L
- Align Technology, Inc.
- Aligntech de Mexico S, de R. L. de C. V.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
