ET III SA ULTRA WIDE SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K103537
Device Name ET III SA ULTRA WIDE SYSTEM
Applicant
HIOSSEN INC.
85 ben fairless drive
fairless hills, 
PA 
19030

Applicant Contact patrick lim
Correspondent
HIOSSEN INC.
85 ben fairless drive
fairless hills, 
PA 
19030

Correspodent Contact patrick lim
Regulation Number 872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received 12/02/2010
Decision Date 03/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No