Cleared Traditional

SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD

K984508 · W&H Dentalwerk Buermoos GmbH · Dental

Jun 1999

Decision

189d

Days

Class 1

Risk

About This 510(k) Submission

K984508 is an FDA 510(k) clearance for the SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD, a Drill, Dental, Intraoral (Class I — General Controls, product code DZA), submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on June 25, 1999, 189 days after receiving the submission on December 18, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.4130.

Submission Details

510(k) Number	K984508 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 1998
Decision Date	June 25, 1999
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement