3D Predict

Aligner, Sequential

3D Smile USA, Inc

The following data is part of a premarket notification filed by 3d Smile Usa, Inc with the FDA for 3d Predict.

Pre-market Notification Details

Device IDK200214
510k NumberK200214
Device Name:3D Predict
ClassificationAligner, Sequential
Applicant 3D Smile USA, Inc 3675 Market Street Suite #200 Philadelphia,  PA  19104
ContactMarina Domracheva
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-01-28
Decision Date2020-02-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D9393DS080 K200214 000

Trademark Results [3D Predict]

Mark Image

Registration | Serial
Company
Trademark
Application Date
3D PREDICT
3D PREDICT
88733773 not registered Live/Pending
3D Smile USA Inc.
2019-12-19

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.