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510(k) K933501

ALASTIK by Unitek Corp. — Product Code EJF

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

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  • K911271 — ADHESIVE PRECOATED BRACKETS (May 29, 1991)
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  • K890529 — ALASTIGARD (March 9, 1989)
  • K880392 — ORTHOLUX VISIBLE LIGHT CURING UNIT (April 7, 1988)

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