EJHClass II
Alloy, Metal, Base
21 CFR 872.3710 / Dental
EJH is the FDA product code for Alloy, Metal, Base, a class II device type, regulated under 21 CFR 872.3710. As of , FDA records hold 153 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- EJH
- Device name
- Alloy, Metal, Base
- Regulation
- 21 CFR 872.3710
- Device class
- Class II
- 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
- 153
- Ingested recalls
- 0
Clearances, product code EJH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 3 |
| 1980 | 1 |
| 1981 | 7 |
| 1982 | 7 |
| 1983 | 4 |
| 1984 | 5 |
| 1985 | 11 |
| 1986 | 13 |
| 1987 | 2 |
| 1988 | 3 |
| 1989 | 1 |
| 1990 | 3 |
| 1991 | 8 |
| 1992 | 4 |
| 1993 | 4 |
| 1994 | 10 |
| 1995 | 7 |
| 1996 | 2 |
| 1997 | 9 |
| 1998 | 3 |
| 1999 | 6 |
| 2000 | 11 |
| 2001 | 6 |
| 2002 | 10 |
| 2003 | 9 |
| 2004 | 2 |
| 2013 | 1 |
Applicants with the most clearances
Product code EJH| Applicant | Clearances |
|---|---|
| Aalba Dent, Inc. | 18 |
| Jeneric Ind. | 12 |
| Austenal Dental, Inc. | 6 |
| Jeneric/Pentron, Inc. | 6 |
| American Dent-All, Inc. | 5 |
| Dental Alloy Products, Inc. | 5 |
| Dentsply Intl. | 5 |
| Neirynck & Vogt NV | 5 |
| North American Alloys, Inc. | 5 |
| Williams Gold Refining Co., Inc. | 5 |
Companies listing this code with FDA
Companies whose registered establishments list this code- A.D.L. Dental Lab
- Aalba Dent, Inc.
- Acnis Titanium & Alloys Inc.
- Adentatec GmbH
- Amann Girrbach AG
- Amann Girrbach North America, LP
- Arvit Dental Laboratory Inc.
- Avimetal AM (Xuzhou) Co., Ltd.
- Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & Co. KG
- Bernard Cervos Societe (B.C.S) S.A.S
- Best Value Ceramics Inc
- Bredent GmbH & Co.KG
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.
