EJTClass II
Alloy, Gold-Based Noble Metal
21 CFR 872.3060 / Dental
EJT is the FDA product code for Alloy, Gold-Based Noble Metal, a class II device type, regulated under 21 CFR 872.3060. As of , FDA records hold 627 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- EJT
- Device name
- Alloy, Gold-Based Noble Metal
- Regulation
- 21 CFR 872.3060
- 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
- 627
- Ingested recalls
- 0
Clearances, product code EJT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 3 |
| 1978 | 3 |
| 1979 | 5 |
| 1981 | 1 |
| 1982 | 9 |
| 1983 | 4 |
| 1985 | 5 |
| 1986 | 1 |
| 1987 | 3 |
| 1988 | 11 |
| 1989 | 100 |
| 1990 | 66 |
| 1991 | 31 |
| 1992 | 9 |
| 1993 | 28 |
| 1994 | 99 |
| 1995 | 42 |
| 1996 | 32 |
| 1997 | 34 |
| 1998 | 9 |
| 1999 | 9 |
| 2000 | 22 |
| 2001 | 25 |
| 2002 | 36 |
| 2003 | 31 |
| 2004 | 6 |
| 2005 | 1 |
Applicants with the most clearances
Product code EJT| Applicant | Clearances |
|---|---|
| Argen Precious Metals, Inc. | 201 |
| J.F. Jelenko & Co., Inc. | 38 |
| Metalor Dental USA Corp. | 31 |
| Ivoclar North America, Inc. | 29 |
| Gateway Alloys, Inc. | 27 |
| Leach and Dillon Co., Inc. | 27 |
| Degussa AG | 26 |
| Wieland Dental + Technik GmbH & Co. KG | 23 |
| Deringer-Ney, Inc. | 22 |
| Macdonald Metals and Ceramics | 22 |
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.
