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FDA 510(k)

Glidewell TuffSplint™ Appliance Resin

K-Number: K223798 · 2023-02-17

ApplicantPrismatik Dentalcraft, Inc.
Decision Date2023-02-17
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

Glidewell TuffSplint™ Appliance Resin is the device name listed in this FDA 510(k) record. The listed applicant is Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K223798. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Glidewell TuffSplint™ Appliance Resin?

Glidewell TuffSplint™ Appliance Resin is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K223798.

When did Glidewell TuffSplint™ Appliance Resin receive FDA 510(k) clearance?

Glidewell TuffSplint™ Appliance Resin received FDA 510(k) clearance on 2023-02-17, under 510(k) number K223798.

Who is the listed applicant for Glidewell TuffSplint™ Appliance Resin?

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

What is the FDA product code for Glidewell TuffSplint™ Appliance Resin?

The FDA product code for Glidewell TuffSplint™ Appliance Resin is MQC.

Other records listing Prismatik Dentalcraft, 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.

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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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