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510(k) K934265

FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE by Flexmedics — Product Code DZC

K934265 is an FDA 510(k) premarket notification submitted by Flexmedics for the device "FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE". The FDA issued a decision of Substantially Equivalent on January 21, 1994. The device falls under product code DZC (Wire, 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 21, 1994
Date Received
August 31, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, 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)
  • 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)
  • K885086 — TIN COATED NITI ORTHODONTIC ARCH WIRES (January 10, 1989)

Other clearances for product code DZC

  • K112640 — HYPERELASTIC WIRE (November 16, 2011)
  • K943334 — HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT (October 5, 1994)
  • K935638 — NITINOL, NITI (May 18, 1994)
  • K935140 — DENTAURUM STEEL LIGATURE WIRES (February 4, 1994)
  • K935142 — DENTAURUM WIRES (January 31, 1994)
  • K933374 — NITI COIL SPRINGS (November 19, 1993)
  • K933377 — STAINLESS STEEL ARCHES REPACKER RELABETER (November 16, 1993)
  • K933379 — STAINLESS STEEL ARCHES (November 12, 1993)
  • K933380 — REVERSE SURVE NITI ARCH WIRE (November 12, 1993)
  • K933376 — NITI ARCH WIRE ON A SPOOL (November 12, 1993)

FDA data resources