HAPTITE COATING IMPLANT SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K111364
Device Name HAPTITE COATING IMPLANT SYSTEM
Applicant
DENTIS CO., LTD.
325 n. puente street
unit b
brea, 
CA 
92821

Applicant Contact april lee
Correspondent
DENTIS 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 05/16/2011
Decision Date 02/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No