MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)


Device Classification Name

material, tooth shade, resin

510(k) Number K021250
Device Name MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)
Original Applicant
HANDPIECE UNLIMITED
katharinenstr. 5
lubeck, 

DE

23554

Original Contact martina gunderoth
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 04/19/2002
Decision Date 10/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No