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510(k) K935142

DENTAURUM WIRES by Dentauraum, Inc. — Product Code DZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1994
Date Received
October 28, 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 Dentauraum, Inc.

  • K952866 — REMATITAN TITANIUM (July 27, 1995)
  • K952867 — REMANIUM:GM 700, GM 380, GM 800, GFH (July 27, 1995)
  • K952870 — REMANIUM: CS & G-SOFT (July 27, 1995)
  • K952865 — REMANIUM: 200,CS, 380, AND CD (July 26, 1995)
  • K952868 — DENTAURUM JACKET CROWN & ROOT POSTS (July 19, 1995)
  • K942667 — DENT-O-CRYL ORTHODONTIC ACRYLIC (February 13, 1995)
  • K942666 — ORTHALGENAT IMPRESSION MATERIAL (August 10, 1994)
  • K936151 — EXTRAORAL HEADGEAR (August 1, 1994)
  • K942668 — O-TRAY IMPRESSION TRAYS (July 22, 1994)
  • K942665 — ORTHOCENT: LIQUID AND POWDER (July 22, 1994)

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)
  • 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)
  • K933376 — NITI ARCH WIRE ON A SPOOL (November 12, 1993)