Cleared Traditional

K934265 - FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE
(FDA 510(k) Clearance)

K934265 · Flexmedics · Dental device

Jan 1994

Decision

143d

Days

Class 1

Risk

K934265 is an FDA 510(k) clearance for the FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE. This device is classified as a Wire, Orthodontic (Class I - General Controls, product code DZC).

Submitted by Flexmedics (Minnetonka, US). The FDA issued a Cleared decision on January 21, 1994, 143 days after receiving the submission on August 31, 1993.

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

Submission Details

510(k) Number	K934265 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 31, 1993
Decision Date	January 21, 1994
Days to Decision	143 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement