STAINLESS STEEL ARCHES REPACKER RELABETER— 510(k) K933377

Name: FDA 510(k) clearance K933377
Creator: U.S. Food and Drug Administration
Published: 1993-11-16

Substantially Equivalent

Highland Metals

FDA 510(k) clearance K933377 for STAINLESS STEEL ARCHES REPACKER RELABETER, Substantially Equivalent on 1993-11-16. 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: 1993-07-09
Decision date: 1993-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZC

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K112640 — HYPERELASTIC WIRE2011-11-16
K943334 — HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT1994-10-05
K935638 — NITINOL, NITI1994-05-18
K935140 — DENTAURUM STEEL LIGATURE WIRES1994-02-04
K935142 — DENTAURUM WIRES1994-01-31

More clearances from Highland Metals

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K933374 — NITI COIL SPRINGS1993-11-19
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
K933380 — REVERSE SURVE NITI ARCH WIRE1993-11-12

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