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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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 Number872.5470
Classification Product Code
NXC  
Date Received09/15/2020
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
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