FDA product code JEX: Plier, Orthodontic
JEX is the FDA product code for plier, orthodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 7 510(k) submissions under JEX, from 5 different applicants. The average 510(k) review took 56 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Plier, Orthodontic |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JEX clearance
Top JEX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Unitek Corp. | 3 | 1992-11-25 |
| Sybron Dental Specialties, Inc. | 1 | 1995-12-01 |
| Dentauraum, Inc. | 1 | 1994-01-31 |
| Unitex Corp. | 1 | 1985-11-26 |
| Adp Intl., Inc. | 1 | 1976-11-15 |
Most recent JEX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K955242 | Sybron Dental Specialties, Inc. | TITANIUM BIRD BEAK PLIER | 1995-12-01 | 16 |
| K935141 | Dentauraum, Inc. | DENTAURUM PLIERS | 1994-01-31 | 95 |
| K924645 | Unitek Corp. | TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS | 1992-11-25 | 72 |
| K924295 | Unitek Corp. | DEBRACKETING INSTRUMENT | 1992-11-23 | 89 |
| K854088 | Unitex Corp. | UNITEK LIFT-OFF DEBRACKETING INSTRUMENT | 1985-11-26 | 50 |
Recalls for JEX devices
openFDA lists no recalls for product code JEX.
Frequently asked questions
What is FDA product code JEX?
JEX is the FDA product code for plier, orthodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is JEX?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JEX?
Across 7 cleared submissions the average was 56 days from receipt to decision (median 50).
Which companies have the most JEX clearances?
Unitek Corp. (3); Sybron Dental Specialties, Inc. (1); Dentauraum, Inc. (1); Unitex Corp. (1); Adp Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JEX
- Run a recall and safety report across every JEX manufacturer
- Watch product code JEX 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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