Night Guard
K-Number: K202465 · 2020-11-25
Applicant3D Diagnostix, Inc.
Decision Date2020-11-25
Product CodeMQC
DecisionSubstantially Equivalent
Device Summary
Night Guard is a medical device manufactured by 3D Diagnostix, Inc.. It received FDA 510(k) clearance on 2020-11-25 under approval number K202465. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Night Guard?
Night Guard is a medical device that received FDA 510(k) clearance on 2020-11-25. It is manufactured by 3D Diagnostix, Inc.. The 510(k) number is K202465.
When was Night Guard approved by the FDA?
Night Guard received FDA 510(k) clearance on 2020-11-25, under approval number K202465.
What company makes Night Guard?
Night Guard is manufactured by 3D Diagnostix, Inc..
What is the FDA product code for Night Guard?
The FDA product code for Night Guard is MQC.
Related Clinical Trials
Other Devices by 3D Diagnostix, Inc.
Related Devices (Code: MQC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.