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510(k) K923838

THE ULTIMATE RCS ARCH WIRE by Ultimate Wireforms, Inc. — Product Code DZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 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)
  • K923839 — NITINOL GENTLE TOUCH COIL SPRING (October 15, 1992)

Other clearances for product code DZC

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  • 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)
  • K933378 — REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER (November 12, 1993)
  • K933380 — REVERSE SURVE NITI ARCH WIRE (November 12, 1993)