Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K040539 |
Device Name |
ELLIPTIC MATRIX |
Applicant |
INSTITUT STRAUMANN AG |
RESERVOIR PLACE |
1601 TRAPELO ROAD |
WALTHAM,
MA
02451
|
|
Applicant Contact |
JOHN KING |
Correspondent |
INSTITUT STRAUMANN AG |
RESERVOIR PLACE |
1601 TRAPELO ROAD |
WALTHAM,
MA
02451
|
|
Correspondent Contact |
JOHN KING |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 03/02/2004 |
Decision Date | 03/18/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|