Cleared Traditional

K870765 - CANNULATED INSTRUMENT CLEANERS
(FDA 510(k) Clearance)

K870765 · Treace Medical, Inc. · Dental device

May 1987

Decision

90d

Days

Class 1

Risk

K870765 is an FDA 510(k) clearance for the CANNULATED INSTRUMENT CLEANERS. This device is classified as a Broach, Endodontic (Class I - General Controls, product code EKW).

Submitted by Treace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on May 27, 1987, 90 days after receiving the submission on February 26, 1987.

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

Submission Details

510(k) Number	K870765 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 26, 1987
Decision Date	May 27, 1987
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—