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510(k) K924295

DEBRACKETING INSTRUMENT by Unitek Corp. — Product Code JEX

K924295 is an FDA 510(k) premarket notification submitted by Unitek Corp. for the device "DEBRACKETING INSTRUMENT". The FDA issued a decision of Substantially Equivalent on November 23, 1992. The device falls under product code JEX (Plier, Orthodontic), a Class I device regulated under 21 CFR 872.4565. Unitek Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1992
Date Received
August 26, 1992
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

Other clearances by Unitek Corp.

  • K944286 — METAL-LINED TRANSCEND CERAMIC BRACKET (November 29, 1994)
  • K933501 — ALASTIK (April 28, 1994)
  • K940165 — ALASTIK (March 7, 1994)
  • K923999 — ALASTIK NS (June 24, 1993)
  • K924645 — TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS (November 25, 1992)
  • K923432 — GERMAN MINI DYNALOCK (October 30, 1992)
  • K911271 — ADHESIVE PRECOATED BRACKETS (May 29, 1991)
  • K910288 — NONSTAINING ALASTIKS (March 29, 1991)
  • K890529 — ALASTIGARD (March 9, 1989)
  • K880392 — ORTHOLUX VISIBLE LIGHT CURING UNIT (April 7, 1988)

Other clearances for product code JEX

  • K955242 — TITANIUM BIRD BEAK PLIER (December 1, 1995)
  • K935141 — DENTAURUM PLIERS (January 31, 1994)
  • K924645 — TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS (November 25, 1992)
  • K854088 — UNITEK LIFT-OFF DEBRACKETING INSTRUMENT (November 26, 1985)
  • K843742 — UNITEK CONVERTIBLE CAP REMOVER TOOL (November 9, 1984)
  • K760984 — ORTHODONTIC INSTRUMENTS (November 15, 1976)

FDA data resources