ET II BIO-SA FIXTURE SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K112532
Device Name ET II BIO-SA FIXTURE 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  
Date Received 08/31/2011
Decision Date 08/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No