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 ID | K200214 |
| 510k Number | K200214 |
| Device Name: | 3D Predict |
| Classification | Aligner, Sequential |
| Applicant | 3D Smile USA, Inc 3675 Market Street Suite #200 Philadelphia, PA 19104 |
| Contact | Marina Domracheva |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-01-28 |
| Decision Date | 2020-02-24 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D9393DS080 | K200214 | 000 |
Trademark Results [3D Predict]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 3D PREDICT 90818228 not registered Live/Pending |
KIYATEC Inc. 2021-07-08 |
 3D PREDICT 88733773 not registered Live/Pending |
3D Smile USA Inc. 2019-12-19 |
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