ANYRIDGE INTERNAL IMPLANT SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K110955
Device Name ANYRIDGE INTERNAL IMPLANT SYSTEM
Applicant
MEGAGEN CO., LTD.
325 n. puente street
unit b
brea, 
CA 
92821

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

Correspodent Contact april lee
Regulation Number 872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received 04/05/2011
Decision Date 11/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No