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510(k) K994357

BITEM LOCK, MODELS SW006, SW012 by Thermoelastic Technologies, Inc. — Product Code EJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2000
Date Received
December 27, 1999
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 Thermoelastic Technologies, Inc.

  • K012882 — BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 (November 14, 2001)

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