Cleared Traditional

K933376 - NITI ARCH WIRE ON A SPOOL (FDA 510(k) Clearance)

K933376 · Highland Metals · Dental device

Nov 1993

Decision

126d

Days

Class 1

Risk

K933376 is an FDA 510(k) clearance for the NITI ARCH WIRE ON A SPOOL. This device is classified as a Wire, Orthodontic (Class I - General Controls, product code DZC).

Submitted by Highland Metals (San Jose, US). The FDA issued a Cleared decision on November 12, 1993, 126 days after receiving the submission on July 9, 1993.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number	K933376 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 09, 1993
Decision Date	November 12, 1993
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement