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510(k) K994357

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

K994357 is an FDA 510(k) premarket notification submitted by Thermoelastic Technologies, Inc. for the device "BITEM LOCK, MODELS SW006, SW012". The FDA issued a decision of Substantially Equivalent on March 14, 2000. The device falls under product code EJF (Bracket, Metal, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Thermoelastic Technologies, Inc. has at least 1 other 510(k) clearance on record.

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)

Other clearances for product code EJF

  • K932825 — MICROARCH GOLD BRACKET (May 9, 1994)
  • K933501 — ALASTIK (April 28, 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)
  • K926427 — LARIAT PALATE EXPANDER (January 26, 1994)
  • K925028 — FORESTADENT ORTHODONTIC BANDS (January 26, 1994)

FDA data resources