EJPClass I
Articulators
21 CFR 872.3150 / Dental
EJP is the FDA product code for Articulators, a class I device type, regulated under 21 CFR 872.3150. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- EJP
- Device name
- Articulators
- Regulation
- 21 CFR 872.3150
- Device class
- Class I
- Review panel
- Dental
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 11
- Ingested recalls
- 0
Clearances, product code EJP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1981 | 2 |
| 1983 | 1 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 2 |
| 1994 | 1 |
Applicants with the most clearances
Product code EJP| Applicant | Clearances |
|---|---|
| Almore Intl., Inc. | 2 |
| Alrand, Inc. | 1 |
| Bauer, Cheng & Associates, Inc. | 1 |
| Dentsply Intl. | 1 |
| Ivoclar North America, Inc. | 1 |
| Premier Medical | 1 |
| Sds Dental, Inc. | 1 |
| Shofu Dental Corp. | 1 |
| Texapol Corp. | 1 |
| Williams Gold Refining Co., Inc. | 1 |
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.
