Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K020096 |
Device Name |
ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM |
Applicant |
INSTITUT STRAUMANN AG |
RESERVOIR PLACE |
1601 TRAPELO ROAD |
WALTHAM,
MA
02451
|
|
Applicant Contact |
LINDA JALBERT |
Correspondent |
INSTITUT STRAUMANN AG |
RESERVOIR PLACE |
1601 TRAPELO ROAD |
WALTHAM,
MA
02451
|
|
Correspondent Contact |
LINDA JALBERT |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 01/11/2002 |
Decision Date | 02/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|