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510(k) K854088

UNITEK LIFT-OFF DEBRACKETING INSTRUMENT by Unitex Corp. — Product Code JEX

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

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  • K924645 — TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS (November 25, 1992)
  • K924295 — DEBRACKETING INSTRUMENT (November 23, 1992)
  • K843742 — UNITEK CONVERTIBLE CAP REMOVER TOOL (November 9, 1984)
  • K760984 — ORTHODONTIC INSTRUMENTS (November 15, 1976)