FDA product code EJP: Articulators
EJP is the FDA product code for articulators. It is a Class I device, regulated under 21 CFR 872.3150 and reviewed by the Dental panel. FDA has cleared 11 510(k) submissions under EJP, from 10 different applicants. The average 510(k) review took 74 days (median 33).
Classification
| Field | Value |
|---|---|
| Device name | Articulators |
| Device class | Class I |
| Regulation | 21 CFR 872.3150 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EJP clearance
Top EJP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Almore Intl., Inc. | 2 | 1986-03-06 |
| Alrand, Inc. | 1 | 1994-01-18 |
| Ivoclar North America, Inc. | 1 | 1989-12-04 |
| Texapol Corp. | 1 | 1989-06-12 |
| Premier Medical | 1 | 1988-11-14 |
5 more applicants have EJP clearances. See the full list in Caduvo.
Most recent EJP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K926190 | Alrand, Inc. | ALRAND INC. (DENTAL HAND INSTRUMENTS) | 1994-01-18 | 405 |
| K896131 | Ivoclar North America, Inc. | GNATHOMAT ARTICULATOR | 1989-12-04 | 42 |
| K892373 | Texapol Corp. | DENTAL PLASTIC BITE FORK | 1989-06-12 | 67 |
| K884418 | Premier Medical | PREMIER DIE-TRAK ARTICULATOR | 1988-11-14 | 25 |
| K872943 | Dentsply Intl. | DISPOSABLE ARTICULATOR | 1987-08-11 | 14 |
Recalls for EJP devices
openFDA lists no recalls for product code EJP.
Frequently asked questions
What is FDA product code EJP?
EJP is the FDA product code for articulators. It is a Class I device, regulated under 21 CFR 872.3150 and reviewed by the Dental panel.
What device class is EJP?
Class I, regulation 21 CFR 872.3150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EJP?
Across 11 cleared submissions the average was 74 days from receipt to decision (median 33).
Which companies have the most EJP clearances?
Almore Intl., Inc. (2); Alrand, Inc. (1); Ivoclar North America, Inc. (1); Texapol Corp. (1); Premier Medical (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EJP
- Run a recall and safety report across every EJP manufacturer
- Watch product code EJP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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