Device Classification Name |
aligner, sequential
|
510(k) Number |
K182388 |
Device Name |
Krystal Klear Aligners |
Applicant |
Shatkin F.I.R.S.T. LLC |
2495 Kensington Avenue |
Amherst,
NY
14226
|
|
Applicant Contact |
Kimberly Wiesmore |
Correspondent |
Shatkin F.I.R.S.T. LLC |
2495 Kensington Avenue |
Amherst,
NY
14226
|
|
Correspondent Contact |
Kimberly Wiesmore |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 09/04/2018 |
Decision Date | 12/19/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|