Device Classification Name |
Aligner, Sequential
|
510(k) Number |
K182658 |
Device Name |
Bioliner |
Applicant |
Five Star Orthodontic Lab & Supply |
2928 Metro Street, Suite 102 |
Denton,
TX
76207
|
|
Applicant Contact |
Andrew Loch |
Correspondent |
Five Star Orthodontic Lab & Supply |
2928 Metro Street, Suite 102 |
Denton,
TX
76207
|
|
Correspondent Contact |
Andrew Loch |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 09/25/2018 |
Decision Date | 06/19/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|