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FDA 510(k)

Panthera Occlusal Appliance

K-Number: K203596 · 2021-04-20

ApplicantPanthera Dental, Inc.
Decision Date2021-04-20
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

Panthera Occlusal Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Panthera Dental, Inc.. It received FDA 510(k) clearance on 2021-04-20 under 510(k) number K203596. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Panthera Occlusal Appliance?

Panthera Occlusal Appliance is a medical device that received FDA 510(k) clearance on 2021-04-20. The listed applicant is Panthera Dental, Inc.. The 510(k) number is K203596.

When did Panthera Occlusal Appliance receive FDA 510(k) clearance?

Panthera Occlusal Appliance received FDA 510(k) clearance on 2021-04-20, under 510(k) number K203596.

Who is the listed applicant for Panthera Occlusal Appliance?

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

What is the FDA product code for Panthera Occlusal Appliance?

The FDA product code for Panthera Occlusal Appliance is MQC.

Other records listing Panthera Dental, 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.

K192108Panthera Dental Milled BarsK183580Panthera Dental Milled BarsK171576The Panthera Anti-Snoring X3 DeviceK173466Panthera Dental Milled Bars

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

View on FDA Database →

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

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