Device Classification Name |
implant, endosseous, orthodontic
|
510(k) Number |
K201919 |
Device Name |
Blue Sky Bio TAD |
Applicant |
Blue Sky Bio, LLC. |
800 Liberty Drive |
Libertyville,
IL
60048
|
|
Applicant Contact |
Sharon Nichols |
Correspondent |
Compliance 4 Devices |
118 W Prive Cr. |
Delray Beach,
FL
33445
|
|
Correspondent Contact |
Juan Tezak |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 07/10/2020 |
Decision Date | 12/17/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|