ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT


definition

Device Classification Name

implant, endosseous, root-form

510(k) Number K002374
Device Name ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT
Original Applicant
STRAUMANN USA
reservoir place,
1601 trapelo road
waltham, 
MA 
02154

Original Contact linda jalbert
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 08/04/2000
Decision Date 11/01/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No