Cleared Traditional

K812692 - FILES & REAMERS
(FDA 510(k) Clearance)

K812692 · Miltex Instrument Co. · Dental

Oct 1981

Decision

31d

Days

Class 1

Risk

K812692 is an FDA 510(k) clearance for the FILES & REAMERS. This device is classified as a File, Pulp Canal, Endodontic (Class I — General Controls, product code EKS).

Submitted by Miltex Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1981, 31 days after receiving the submission on September 22, 1981.

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

Submission Details

510(k) Number	K812692 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 1981
Decision Date	October 23, 1981
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—