Cleared Traditional

ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS

K935443 · Osada Electric Co., Ltd. · Dental

Sep 1994

Decision

312d

Days

Class 2

Risk

About This 510(k) Submission

K935443 is an FDA 510(k) clearance for the ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS, a Saw, Bone, Ac-powered (Class II — Special Controls, product code DZH), submitted by Osada Electric Co., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on September 20, 1994, 312 days after receiving the submission on November 12, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number	K935443 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 1993
Decision Date	September 20, 1994
Days to Decision	312 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement