INCLUSIVE TAPERED IMPLANT SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K121406
Device Name INCLUSIVE TAPERED IMPLANT SYSTEM
Applicant
PRISMATIK DENTALCRAFT, INC.
2212 dupont dr., st p
irvine, 
CA 
92612

Applicant Contact armin zehtabchi
Correspondent
PRISMATIK DENTALCRAFT, INC.
2212 dupont dr., st p
irvine, 
CA 
92612

Correspodent Contact armin zehtabchi
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 05/10/2012
Decision Date 02/22/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No