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FDA 510(k)

Night Guard

K-Number: K202465 · 2020-11-25

Applicant3D Diagnostix, Inc.
Decision Date2020-11-25
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

Night Guard is the device name listed in this FDA 510(k) record. The listed applicant is 3D Diagnostix, Inc.. It received FDA 510(k) clearance on 2020-11-25 under 510(k) 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. The listed applicant is 3D Diagnostix, Inc.. The 510(k) number is K202465.

When did Night Guard receive FDA 510(k) clearance?

Night Guard received FDA 510(k) clearance on 2020-11-25, under 510(k) number K202465.

Who is the listed applicant for Night Guard?

The FDA 510(k) record lists 3D Diagnostix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Night Guard?

The FDA product code for Night Guard is MQC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07548502Effect of Night Guard Use on Masseter Muscle Thickness in Children With BruxismRECRUITING

Other records listing 3D Diagnostix, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200908iSMILE

Related Devices (Code: MQC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemviaK251252NOBILCAM IMPAK DiscShandong Huge Dental Material CorporationK241729Hard Splint & Thermo-Adaptive SplintWhip Mix CorporationK243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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