Cleared Traditional

K935142 - DENTAURUM WIRES
(FDA 510(k) Clearance)

K935142 · Dentauraum, Inc. · Dental device

Jan 1994

Decision

95d

Days

Class 1

Risk

K935142 is an FDA 510(k) clearance for the DENTAURUM WIRES. This device is classified as a Wire, Orthodontic (Class I - General Controls, product code DZC).

Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on January 31, 1994, 95 days after receiving the submission on October 28, 1993.

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

Submission Details

510(k) Number	K935142 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 28, 1993
Decision Date	January 31, 1994
Days to Decision	95 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement