CSM SUBMERGED-R IMPLANT SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K111120
Device Name CSM SUBMERGED-R IMPLANT SYSTEM
Applicant
CSMIMPLANT
325 n. puente st. unit b
brea, 
CA 
92821

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

Correspodent Contact april lee
Regulation Number 872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received 04/21/2011
Decision Date 10/14/2011
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Dental

510k Review Panel

Dental
summary

summary

Type Traditional
Reviewed by Third Party No
Combination Product

No