Product code JEX
- Device name
- Plier, Orthodontic
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4565
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K955242 | TITANIUM BIRD BEAK PLIER | Sybron Dental Specialties, Inc. | 1995-12-01 |
| K935141 | DENTAURUM PLIERS | Dentauraum, Inc. | 1994-01-31 |
| K924645 | TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS | Unitek Corp. | 1992-11-25 |
| K924295 | DEBRACKETING INSTRUMENT | Unitek Corp. | 1992-11-23 |
| K854088 | UNITEK LIFT-OFF DEBRACKETING INSTRUMENT | Unitex Corp. | 1985-11-26 |
| K843742 | UNITEK CONVERTIBLE CAP REMOVER TOOL | Unitek Corp. | 1984-11-09 |
| K760984 | ORTHODONTIC INSTRUMENTS | Adp Intl., Inc. | 1976-11-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G8791050960 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791053030 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791053020 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791053010 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791052280 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791052160 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G87910515910 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791051590 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791051530 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791051440 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G87910513910 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791051390 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791051040 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791050990 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791050980 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791031420 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791050950 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791050890 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G879105085M0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791050850 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791050810 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791050770 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791050680 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791050670 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791050660 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791050140 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791050120 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791050020 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791050010 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |
| G8791031430 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-14 |