EIDClass I
Syringe, Restorative And Impression Material
21 CFR 872.4565 / Dental
EID is the FDA product code for Syringe, Restorative And Impression Material, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- EID
- Device name
- Syringe, Restorative And Impression Material
- 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
- 13
- Ingested recalls
- 1
Clearances, product code EID
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 1 |
| 1981 | 3 |
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 2 |
| 1992 | 1 |
| 1994 | 1 |
Applicants with the most clearances
Product code EID| Applicant | Clearances |
|---|---|
| Centrix, Inc. | 2 |
| Dentsply Intl. | 2 |
| Espe GmbH (US) | 2 |
| Bio-Interfaces, Inc. | 1 |
| Caulk Co., Div. Dentsply | 1 |
| Cavitron Corp. | 1 |
| Coltene, Inc. | 1 |
| G-C Intl. Corp. | 1 |
| Lee Pharmaceuticals | 1 |
| Unitek Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- 3D Dental Desings and Development
- Acme Commercial Ways Ltd.
- Amedcon Medical Technology (Shenzhen) Co., Ltd.
- Anhui Chuangnuo Medical equipment Co., Ltd
- Anqing Clean Dental Instrument Technology Co.,Ltd
- ASA Dental S.p.A.
- Aspen Surgical Products, Inc.
- Atomo Dental, Inc.
- Battech
- Bausch & Lomb Incorporated
- Beyes Dental Inc
- Bgss Company Asia Limited
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.
