JEX
7 FDA 510(k) clearances · Product code
50 daysmedian time to decision
95 days90th percentile
7clearances measured
FDA profile
- Official device name
- Plier, Orthodontic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1998: 1 · 2005: 20 · 2006: 41 · 2007: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TITANIUM BIRD BEAK PLIER (K955242) | Sybron Dental Specialties, Inc. | 1995-12-01 |
| DENTAURUM PLIERS (K935141) | Dentauraum, Inc. | 1994-01-31 |
| TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS (K924645) | Unitek Corp. | 1992-11-25 |
| DEBRACKETING INSTRUMENT (K924295) | Unitek Corp. | 1992-11-23 |
| UNITEK LIFT-OFF DEBRACKETING INSTRUMENT (K854088) | Unitex Corp. | 1985-11-26 |
| UNITEK CONVERTIBLE CAP REMOVER TOOL (K843742) | Unitek Corp. | 1984-11-09 |
| ORTHODONTIC INSTRUMENTS (K760984) | Adp Intl., Inc. | 1976-11-15 |
Track JEX automatically
Every clearance here is in the API, with alerts when new ones post.