Cleared Traditional

K935542 - NICKEL-TITANIUM K-TYPE FILE (FDA 510(k) Clearance)

K935542 · Union Broach, Div. Moyco Industries, Inc. · Dental device

Jan 1994

Decision

48d

Days

Class 1

Risk

K935542 is an FDA 510(k) clearance for the NICKEL-TITANIUM K-TYPE FILE. This device is classified as a File, Pulp Canal, Endodontic (Class I - General Controls, product code EKS).

Submitted by Union Broach, Div. Moyco Industries, Inc. (Emigsville, US). The FDA issued a Cleared decision on January 3, 1994, 48 days after receiving the submission on November 16, 1993.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K935542 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 16, 1993
Decision Date	January 03, 1994
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement