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510(k) K910288

NONSTAINING ALASTIKS by Unitek Corp. — Product Code EJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1991
Date Received
January 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Metal, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

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  • K924645 — TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS (November 25, 1992)
  • K924295 — DEBRACKETING INSTRUMENT (November 23, 1992)
  • K923432 — GERMAN MINI DYNALOCK (October 30, 1992)
  • K911271 — ADHESIVE PRECOATED BRACKETS (May 29, 1991)
  • K890529 — ALASTIGARD (March 9, 1989)
  • K880392 — ORTHOLUX VISIBLE LIGHT CURING UNIT (April 7, 1988)

Other clearances for product code EJF

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  • K923372 — MEMORY WIRE (April 22, 1994)
  • K933080 — ORTHOTECH DURA-GOLD BARCKETS (March 23, 1994)
  • K935139 — FASCINATION CERAMIC BRACKET (February 4, 1994)
  • K936244 — REGENCY BRACKET (February 2, 1994)
  • K934881 — REFLECTIONS (February 1, 1994)
  • K935122 — DENTAURUM METAL BRACKETS (January 31, 1994)
  • K926427 — LARIAT PALATE EXPANDER (January 26, 1994)