EJP
11 FDA 510(k) clearances · Product code
33 daysmedian time to decision
105 days90th percentile
11clearances measured
FDA profile
- Official device name
- Articulators
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3150
- Medical specialty
- Dental
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ALRAND INC. (DENTAL HAND INSTRUMENTS) (K926190) | Alrand, Inc. | 1994-01-18 |
| GNATHOMAT ARTICULATOR (K896131) | Ivoclar North America, Inc. | 1989-12-04 |
| DENTAL PLASTIC BITE FORK (K892373) | Texapol Corp. | 1989-06-12 |
| PREMIER DIE-TRAK ARTICULATOR (K884418) | Premier Medical | 1988-11-14 |
| DISPOSABLE ARTICULATOR (K872943) | Dentsply Intl. | 1987-08-11 |
| GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX (K863009) | Sds Dental, Inc. | 1986-09-25 |
| PLASTIC MOUNTING RINGS (K854702) | Almore Intl., Inc. | 1986-03-06 |
| HANDY IIM (K833039) | Shofu Dental Corp. | 1983-10-04 |
| BALANCE ARTICULATOR (K811075) | Almore Intl., Inc. | 1981-05-13 |
| THE GNATOMET (K810971) | Bauer, Cheng & Associates, Inc. | 1981-05-05 |
| DISPOSABLE ARTICULATOR (K801342) | Williams Gold Refining Co., Inc. | 1980-07-08 |
Track EJP automatically
Every clearance here is in the API, with alerts when new ones post.