510(k) K854088
K854088 is an FDA 510(k) premarket notification submitted by Unitex Corp. for the device "UNITEK LIFT-OFF DEBRACKETING INSTRUMENT". The FDA issued a decision of Substantially Equivalent on November 26, 1985. The device falls under product code JEX (Plier, Orthodontic), a Class I device regulated under 21 CFR 872.4565.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 26, 1985
- Date Received
- October 7, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plier, Orthodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type