The following data is part of a premarket notification filed by Unitek Corp. with the FDA for Debracketing Instrument.
| Device ID | K924295 |
| 510k Number | K924295 |
| Device Name: | DEBRACKETING INSTRUMENT |
| Classification | Plier, Orthodontic |
| Applicant | UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097 |
| Contact | Marlyn Scheff |
| Correspondent | Marlyn Scheff UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097 |
| Product Code | JEX |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-26 |
| Decision Date | 1992-11-23 |