Device Classification Name |
aligner, sequential
|
510(k) Number |
K192069 |
Device Name |
Aerodentis System |
Applicant |
Dror Orthodesign |
7 Hartom St., Mount Hotzvim |
Jerusalem,
IL
9777507
|
|
Applicant Contact |
Michael Nadav |
Correspondent |
Hogan Lovelle US LLP |
1735 Market Street, Suite 2300 |
Philadelphia,
PA
19103
|
|
Correspondent Contact |
Janice M. Hogan |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 08/01/2019 |
Decision Date | 05/06/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|