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510(k) K923372

MEMORY WIRE by Althan, Inc. — Product Code EJF

K923372 is an FDA 510(k) premarket notification submitted by Althan, Inc. for the device "MEMORY WIRE". The FDA issued a decision of Substantially Equivalent on April 22, 1994. The device falls under product code EJF (Bracket, Metal, Orthodontic), a Class I device regulated under 21 CFR 872.5410.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1994
Date Received
July 9, 1992
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 for product code EJF

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  • K932825 — MICROARCH GOLD BRACKET (May 9, 1994)
  • K933501 — ALASTIK (April 28, 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