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510(k) K935638

NITINOL, NITI by Highland Metals — Product Code DZC

K935638 is an FDA 510(k) premarket notification submitted by Highland Metals for the device "NITINOL, NITI". The FDA issued a decision of Substantially Equivalent on May 18, 1994. The device falls under product code DZC (Wire, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Highland Metals has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1994
Date Received
November 23, 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 Highland Metals

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

Other clearances for product code DZC

  • K112640 — HYPERELASTIC WIRE (November 16, 2011)
  • K943334 — HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT (October 5, 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)
  • K933380 — REVERSE SURVE NITI ARCH WIRE (November 12, 1993)

FDA data resources