Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K091026 |
Device Name |
TDS ABUTMENT FOR NOBEL BIOCARE REPLACE |
Applicant |
POU YU BIOTECHNOLOGY CO., LTD. |
NO. 6, FUGONG RD. |
FUSING TOWNSHIP, CHANGHUA CTY,
TW
506
|
|
Applicant Contact |
DANIEL TSAO |
Correspondent |
POU YU BIOTECHNOLOGY CO., LTD. |
NO. 6, FUGONG RD. |
FUSING TOWNSHIP, CHANGHUA CTY,
TW
506
|
|
Correspondent Contact |
DANIEL TSAO |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 04/10/2009 |
Decision Date | 06/24/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|