Device Classification Name |
Aligner, Sequential
|
510(k) Number |
K180346 |
Device Name |
Byte Aligner System |
Applicant |
Straight Smile, LLC |
528 Palisades Drive, #553 |
Pacific Palisades,
CA
90272
|
|
Applicant Contact |
Sepi Abbasi |
Correspondent |
Coombs Medical Device Consulting, Inc. |
1193 Sherman St |
Alameda,
CA
94501
|
|
Correspondent Contact |
Craig Coombs |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 02/08/2018 |
Decision Date | 02/19/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|