Device Classification Name |
Aligner, Sequential
|
510(k) Number |
K183159 |
Device Name |
3M Clarity Aligners |
Applicant |
3M Company |
2510 Conway Avenue |
St. Paul,
MN
55144
|
|
Applicant Contact |
Yanine Garcia-Quezada |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 11/15/2018 |
Decision Date | 11/26/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|