IMTEC SENDAX MDI ORTHO6 AND ORTHO8


Device Classification Name

implant, endosseous, root-form

510(k) Number K023067
Device Name IMTEC SENDAX MDI ORTHO6 AND ORTHO8
Original Applicant
IMTEC CORP.
2401 north commerce
ardmore, 
OK 
73401

Original Contact brad vance
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 09/16/2002
Decision Date 12/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No