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