Home / 510(k) Clearances / K931631

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 Jul 28, 1993. The device falls under product code DZC (Wire, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Wonder Wire has 1 other 510(k) clearance on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 28, 1993
Date Received
Apr 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
510(k) Exempt

Other clearances by Wonder Wire

  • K872622 — ORTHODONTIC ARCH (Oct 9, 1987)

Other clearances for product code DZC

  • K112640 — HYPERELASTIC WIRE (Nov 16, 2011)
  • K943334 — HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT (Oct 5, 1994)
  • K935638 — NITINOL, NITI (May 18, 1994)
  • K935140 — DENTAURUM STEEL LIGATURE WIRES (Feb 4, 1994)
  • K935142 — DENTAURUM WIRES (Jan 31, 1994)
  • K934265 — FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE (Jan 21, 1994)
  • K933374 — NITI COIL SPRINGS (Nov 19, 1993)
  • K933377 — STAINLESS STEEL ARCHES REPACKER RELABETER (Nov 16, 1993)
  • K933379 — STAINLESS STEEL ARCHES (Nov 12, 1993)
  • K933376 — NITI ARCH WIRE ON A SPOOL (Nov 12, 1993)

FDA data resources

Source: FDA 510(k) database entry for K931631. Report a data issue: hello@regdatalab.com.