FDA 510(k)

FREEPRINT® splintmaster

K-Number: K232448 · 2023-10-12

Decision Date2023-10-12

Product CodeMQC

DecisionSubstantially Equivalent

Device Summary

FREEPRINT® splintmaster is the device name listed in this FDA 510(k) record. The listed applicant is Detax GmbH. It received FDA 510(k) clearance on 2023-10-12 under 510(k) number K232448. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FREEPRINT® splintmaster?

FREEPRINT® splintmaster is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is Detax GmbH. The 510(k) number is K232448.

When did FREEPRINT® splintmaster receive FDA 510(k) clearance?

FREEPRINT® splintmaster received FDA 510(k) clearance on 2023-10-12, under 510(k) number K232448.

Who is the listed applicant for FREEPRINT® splintmaster?

The FDA 510(k) record lists Detax GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FREEPRINT® splintmaster?

The FDA product code for FREEPRINT® splintmaster is MQC.

Other records listing Detax GmbH 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.

K252430Freeprint® denture flex K222877FREEPRINT crown

Related Devices (Code: MQC)

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemvia K251252NOBILCAM IMPAK DiscShandong Huge Dental Material Corporation K241729Hard Splint & Thermo-Adaptive SplintWhip Mix Corporation K243516Remi 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.