Device Classification Name |
Aligner, Sequential
|
510(k) Number |
K200005 |
Device Name |
Concinnity Aligners |
Applicant |
Drake Precision Dental Laboratory Inc |
8510 Crown Crescent Ct |
Charlotte,
NC
28227
|
|
Applicant Contact |
Robert Savage |
Correspondent |
BDRA Consulting LLC |
1 Clearwater Court |
Damascus,
MD
20872
|
|
Correspondent Contact |
Srinagesh Koushik |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 01/02/2020 |
Decision Date | 11/09/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|