COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE


Device Classification Name

unit, operative dental

510(k) Number K080677
Device Name COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE
Applicant
KALTENBACH & VOIGT GMBH & CO.
1717 west collins
orange, 
CA 
92867

Applicant Contact claudia ortiz
Correspondent
KALTENBACH & VOIGT GMBH & CO.
1717 west collins
orange, 
CA 
92867

Correspodent Contact claudia ortiz
Regulation Number 872.6640
Classification Product Code
EIA  
Subsequent Product Code
EFB  
Date Received 03/10/2008
Decision Date 06/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No