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510(k) K885086

TIN COATED NITI ORTHODONTIC ARCH WIRES by Flexmedics — Product Code EJF

K885086 is an FDA 510(k) premarket notification submitted by Flexmedics for the device "TIN COATED NITI ORTHODONTIC ARCH WIRES". The FDA issued a decision of Substantially Equivalent on January 10, 1989. The device falls under product code EJF (Bracket, Metal, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Flexmedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1989
Date Received
December 9, 1988
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 Flexmedics

  • K990765 — FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GU (March 15, 1999)
  • K964955 — FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWI (February 14, 1997)
  • K952430 — FINESSE GUIDEWIRE CORONARY (August 18, 1995)
  • K943390 — FLEXFINDER GUIDEWIRE (June 27, 1995)
  • K942074 — FLEXFINDER GUIDEWIRE (June 24, 1994)
  • K934265 — FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE (January 21, 1994)
  • K912843 — FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE (September 24, 1991)
  • K910674 — FLEXMEDICS MALLEABLE CANNULA (April 12, 1991)
  • K895899 — FLEXMEDICS GUIDEWIRE .012 ONLY (May 23, 1990)
  • K893626 — FLEXMEDICS GUIDEWIRE (September 26, 1989)

Other clearances for product code EJF

  • K994357 — BITEM LOCK, MODELS SW006, SW012 (March 14, 2000)
  • 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)
  • K925028 — FORESTADENT ORTHODONTIC BANDS (January 26, 1994)

FDA data resources