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510(k) K923839

NITINOL GENTLE TOUCH COIL SPRING by Ultimate Wireforms, Inc. — Product Code DZC

K923839 is an FDA 510(k) premarket notification submitted by Ultimate Wireforms, Inc. for the device "NITINOL GENTLE TOUCH COIL SPRING". The FDA issued a decision of Substantially Equivalent on October 15, 1992. The device falls under product code DZC (Wire, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Ultimate Wireforms, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1992
Date Received
July 30, 1992
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 Ultimate Wireforms, Inc.

  • K960799 — ORTHO-ICE (May 9, 1996)
  • K923837 — DIMPLED MULTI MODULUS ARCH WIRE (March 31, 1993)
  • K924805 — ORTHODONTIC ARCH WIRE (March 31, 1993)
  • K923836 — .016' X .016 NICKEL TITANIUM UPRIGHTING SPRING (December 23, 1992)
  • K923838 — THE ULTIMATE RCS ARCH WIRE (December 4, 1992)

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)
  • K934265 — FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE (January 21, 1994)
  • K933374 — NITI COIL SPRINGS (November 19, 1993)
  • K933377 — STAINLESS STEEL ARCHES REPACKER RELABETER (November 16, 1993)
  • K933376 — NITI ARCH WIRE ON A SPOOL (November 12, 1993)
  • K933379 — STAINLESS STEEL ARCHES (November 12, 1993)

FDA data resources