Device Classification Name |
dental abutment design software for dental laboratory
|
510(k) Number |
K151455 |
FOIA Releasable 510(k) |
K151455
|
Device Name |
3Shape Abutment Designer Software |
Applicant |
3Shape A/S |
Holemens Kanal 7 |
Copenhagen,
DK
1060
|
|
Applicant Contact |
Hanne Nielsen |
Correspondent |
3Shape A/S |
Holemens Kanal 7 |
Copenhagen,
DK
1060
|
|
Correspondent Contact |
Hanne Nielsen |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 06/01/2015 |
Decision Date | 09/06/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|