TDS ABUTMENT


Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K081460
Device Name TDS ABUTMENT
Applicant
POU YU BIOTECHNOLOGY CO., LTD.
11234 el camino real
suite 200
san diego, 
CA 
92130

Applicant Contact linda k schulz
Correspondent
POU YU BIOTECHNOLOGY CO., LTD.
11234 el camino real
suite 200
san diego, 
CA 
92130

Correspodent Contact linda k schulz
Regulation Number 872.3630
Classification Product Code
NHA  
Date Received 05/23/2008
Decision Date 11/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No