S-MINI IMPLANT SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K112540
Device Name S-MINI IMPLANT SYSTEM
Applicant
NEOBIOTECH CO., LTD.
325 n puente st. unit b
brea, 
CA 
92821

Applicant Contact april lee
Correspondent
NEOBIOTECH CO., LTD.
325 n puente st. unit b
brea, 
CA 
92821

Correspodent Contact april lee
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 09/01/2011
Decision Date 02/03/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No