Cleared Traditional

DENTATUS OSCIOMAT

K031793 · Dentatus USA , Ltd. · Dental

Nov 2003

Decision

156d

Days

Class 2

Risk

About This 510(k) Submission

K031793 is an FDA 510(k) clearance for the DENTATUS OSCIOMAT, a Saw, Bone, Ac-powered (Class II — Special Controls, product code DZH), submitted by Dentatus USA , Ltd. (Sound Beach, US). The FDA issued a Cleared decision on November 13, 2003, 156 days after receiving the submission on June 10, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number	K031793 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 2003
Decision Date	November 13, 2003
Days to Decision	156 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement