IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)


Device Classification Name

controller, foot, handpiece and cord

510(k) Number K002469
Device Name IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
Original Applicant
W & H DENTALWERK BUERMOOS GMBH
ignaz glaser str. 53
buermoos, 

AT

a-5111

Original Contact herbert traschwandtner
Regulation Number 872.4200
Classification Product Code
EBW  
Date Received 08/11/2000
Decision Date 02/07/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No