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510(k) K931631

COATED ORTHODONTIC DEVICES by Wonder Wire — Product Code DZC

K931631 is an FDA 510(k) premarket notification submitted by Wonder Wire for the device "COATED ORTHODONTIC DEVICES". The FDA issued a decision of Substantially Equivalent on July 28, 1993. The device falls under product code DZC (Wire, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Wonder Wire has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1993
Date Received
April 2, 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 Wonder Wire

  • K872622 — ORTHODONTIC ARCH (October 9, 1987)

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