Cleared Traditional

SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11

K011061 · W&H Dentalwerk Buermoos GmbH · Dental

Jun 2001

Decision

83d

Days

Class 1

Risk

About This 510(k) Submission

K011061 is an FDA 510(k) clearance for the SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11, a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on June 28, 2001, 83 days after receiving the submission on April 6, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K011061 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2001
Decision Date	June 28, 2001
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement