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510(k) K112640

HYPERELASTIC WIRE by Ormco Corp. — Product Code DZC

K112640 is an FDA 510(k) premarket notification submitted by Ormco Corp. for the device "HYPERELASTIC WIRE". The FDA issued a decision of Substantially Equivalent on November 16, 2011. The device falls under product code DZC (Wire, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Ormco Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2011
Date Received
September 12, 2011
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 Ormco Corp.

  • K141611 — LYTHOS DIGITAL IMPRESSION SYSTEM (December 5, 2014)
  • K123118 — INSIGNIA DIGICAST (March 26, 2013)
  • K123416 — INSIGNIA WITH ITERO (March 13, 2013)
  • K122065 — DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE (February 8, 2013)
  • K121524 — INSIGNIA (August 9, 2012)
  • K101676 — CLEARARCH (September 13, 2010)
  • K081900 — TEMPORARY TOOTH REPLACEMENT (October 24, 2008)
  • K081415 — DAMON 4CLEAR (September 24, 2008)
  • K062856 — TF ROTARY NICKEL TITANIUM FILE (December 13, 2006)
  • K061481 — GRENGLOO (July 6, 2006)

Other clearances for product code DZC

  • 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)
  • K933380 — REVERSE SURVE NITI ARCH WIRE (November 12, 1993)
  • K933376 — NITI ARCH WIRE ON A SPOOL (November 12, 1993)
  • K933379 — STAINLESS STEEL ARCHES (November 12, 1993)

FDA data resources