EJJClass II
Alloy, Amalgam
21 CFR 872.3070 / Dental
EJJ is the FDA product code for Alloy, Amalgam, a class II device type, regulated under 21 CFR 872.3070. As of , FDA records hold 74 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- EJJ
- Device name
- Alloy, Amalgam
- Regulation
- 21 CFR 872.3070
- Device class
- Class II
- Review panel
- Dental
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 74
- Ingested recalls
- 2
Clearances, product code EJJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 2 |
| 1978 | 3 |
| 1979 | 2 |
| 1980 | 2 |
| 1981 | 2 |
| 1982 | 9 |
| 1984 | 1 |
| 1985 | 1 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 4 |
| 1990 | 6 |
| 1991 | 3 |
| 1992 | 2 |
| 1993 | 4 |
| 1994 | 4 |
| 1995 | 4 |
| 1996 | 2 |
| 1997 | 4 |
| 1998 | 4 |
| 1999 | 1 |
| 2000 | 3 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 3 |
| 2005 | 2 |
Applicants with the most clearances
Product code EJJ| Applicant | Clearances |
|---|---|
| Southern Dental Industries, Inc. | 6 |
| Ab Ardent | 5 |
| Goldsmith & Revere, Inc. | 4 |
| Ivoclar North America, Inc. | 4 |
| Degussa AG | 3 |
| Jeneric/Pentron, Inc. | 3 |
| Johnson & Johnson Professionals, Inc. | 3 |
| Kerr Corporation (Danbury) | 3 |
| Nordiska Dental AB | 3 |
| Ardent Production Development | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.