Device Classification Name |
Aligner, Sequential
|
510(k) Number |
K202685 |
Device Name |
Eon Aligner |
Applicant |
Eon Dental Jordan LLC |
385 King Abdullah II Street |
Amman,
JO
11810
|
|
Applicant Contact |
Fadi Samawi |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 09/15/2020 |
Decision Date | 09/28/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|