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510(k) K933501

ALASTIK by Unitek Corp. — Product Code EJF

K933501 is an FDA 510(k) premarket notification submitted by Unitek Corp. for the device "ALASTIK". The FDA issued a decision of Substantially Equivalent on April 28, 1994. The device falls under product code EJF (Bracket, Metal, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Unitek Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1994
Date Received
July 19, 1993
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

Other clearances by Unitek Corp.

  • K944286 — METAL-LINED TRANSCEND CERAMIC BRACKET (November 29, 1994)
  • K940165 — ALASTIK (March 7, 1994)
  • K923999 — ALASTIK NS (June 24, 1993)
  • 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)
  • 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 EJF

  • K994357 — BITEM LOCK, MODELS SW006, SW012 (March 14, 2000)
  • K932825 — MICROARCH GOLD BRACKET (May 9, 1994)
  • 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)
  • K925028 — FORESTADENT ORTHODONTIC BANDS (January 26, 1994)
  • K926427 — LARIAT PALATE EXPANDER (January 26, 1994)

FDA data resources