Cleared Traditional

SOPHOS DENTAL DIAMOND

K943841 · Sophos Technologic · Dental

Sep 1994

Decision

42d

Days

Class 1

Risk

About This 510(k) Submission

K943841 is an FDA 510(k) clearance for the SOPHOS DENTAL DIAMOND, a Instrument, Diamond, Dental (Class I — General Controls, product code DZP), submitted by Sophos Technologic (San Clemente, US). The FDA issued a Cleared decision on September 16, 1994, 42 days after receiving the submission on August 5, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.4535.

Submission Details

510(k) Number	K943841 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 1994
Decision Date	September 16, 1994
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement