Night Guard

Mouthguard, Prescription

3D Diagnostix Inc.

The following data is part of a premarket notification filed by 3d Diagnostix Inc. with the FDA for Night Guard.

Pre-market Notification Details

• Device ID: K202465
• 510k Number: K202465
• Device Name: Night Guard
• Classification: Mouthguard, Prescription
• Applicant: 3D Diagnostix Inc. 24 Denby Road Allston, MA 02134
• Contact: Ehab Amin
• Correspondent: Ehab Amin; 3D Diagnostix Inc. 24 Denby Road Allston, MA 02134
• Product Code: MQC
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-08-27
• Decision Date: 2020-11-25