Cleared Traditional

K912473 - ACCU-PLACER TM KIT
(FDA 510(k) Clearance)

K912473 · Hu-Friedy Mfg. Co., Inc. · Dental device

Jul 1991

Decision

50d

Days

Class 1

Risk

K912473 is an FDA 510(k) clearance for the ACCU-PLACER TM KIT. This device is classified as a Burnisher, Operative (Class I - General Controls, product code EKJ).

Submitted by Hu-Friedy Mfg. Co., Inc. (Chicago, US). The FDA issued a Cleared decision on July 24, 1991, 50 days after receiving the submission on June 4, 1991.

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

Submission Details

510(k) Number	K912473 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 04, 1991
Decision Date	July 24, 1991
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement