Plier, Orthodontic
An Orthodontic Plier is a hand instrument used by dental professionals to bend, adjust, and manipulate orthodontic wires, brackets, and other components during the fitting and adjustment of orthodontic appliances. It is classified as FDA Class 1 (lowest risk), subject only to general controls including proper labeling and manufacturing standards. The product code is JEX, regulated under 21 CFR 872.4565, within the Dental medical specialty. No special flags apply to this device.
Research product code JEX in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- JEX
- Device Class
- FDA class 1
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K955242 | TITANIUM BIRD BEAK PLIER | Dec 01, 1995 | Substantially Equivalent | Sybron Dental Specialties, Inc. |
| K935141 | DENTAURUM PLIERS | Jan 31, 1994 | Substantially Equivalent | Dentauraum, Inc. |
| K924645 | TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS | Nov 25, 1992 | Substantially Equivalent | Unitek Corp. |
| K924295 | DEBRACKETING INSTRUMENT | Nov 23, 1992 | Substantially Equivalent | Unitek Corp. |
| K854088 | UNITEK LIFT-OFF DEBRACKETING INSTRUMENT | Nov 26, 1985 | Substantially Equivalent | Unitex Corp. |
| K843742 | UNITEK CONVERTIBLE CAP REMOVER TOOL | Nov 09, 1984 | Substantially Equivalent | Unitek Corp. |
| K760984 | ORTHODONTIC INSTRUMENTS | Nov 15, 1976 | Substantially Equivalent | Adp Intl., Inc. |
FEI Numbers
This FDA classification entry is associated with 229 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 229 registration numbers. Click on an entry to view related FDA registrations.