Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K083141 |
Device Name |
SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM |
Applicant |
SIMPACT LLC |
300 INTERPACE PARKWAY |
SUITE 410 |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
MARK SCHENK |
Correspondent |
SIMPACT LLC |
300 INTERPACE PARKWAY |
SUITE 410 |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
MARK SCHENK |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 10/23/2008 |
Decision Date | 11/07/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|