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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 K200214
Device Name 3D Predict
Applicant
3D Smile USA, Inc
3675 Market Street Suite #200
philadelphia,  PA  19104
Applicant Contact marina domracheva
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 Received01/28/2020
Decision Date 02/24/2020
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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