Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K033243 |
Device Name |
ITI SYNOCTA MESO ABUTMENTS |
Applicant |
STRAUMANN USA |
RESERVOIR PLACE, |
1601 TRAPELO ROAD |
WALTHAM,
MA
02154
|
|
Applicant Contact |
LINDA JALBERT |
Correspondent |
STRAUMANN USA |
RESERVOIR PLACE, |
1601 TRAPELO ROAD |
WALTHAM,
MA
02154
|
|
Correspondent Contact |
LINDA JALBERT |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 10/07/2003 |
Decision Date | 10/20/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|