NITINOL, NITI— 510(k) K935638

Substantially Equivalent

Highland Metals

FDA 510(k) clearance K935638 for NITINOL, NITI, Substantially Equivalent on 1994-05-18. Applicant: Highland Metals. Device class: 1.

Clearance details

Applicant: Highland Metals
Product code: Code DZC
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1993-11-23
Decision date: 1994-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZC

K112640 — HYPERELASTIC WIRE2011-11-16
K943334 — HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT1994-10-05
K935140 — DENTAURUM STEEL LIGATURE WIRES1994-02-04
K935142 — DENTAURUM WIRES1994-01-31
K934265 — FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE1994-01-21

More clearances from Highland Metals

K933374 — NITI COIL SPRINGS1993-11-19
K933377 — STAINLESS STEEL ARCHES REPACKER RELABETER1993-11-16
K933376 — NITI ARCH WIRE ON A SPOOL1993-11-12
K933378 — REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER1993-11-12
K933379 — STAINLESS STEEL ARCHES1993-11-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.