FDA 510(k)

LuxaPrint Ortho Plus

K-Number: K210940 · 2021-09-03

Decision Date2021-09-03

Product CodeMQC

DecisionSubstantially Equivalent

Device Summary

LuxaPrint Ortho Plus is the device name listed in this FDA 510(k) record. The listed applicant is Dmg Digital Enterprises SE. It received FDA 510(k) clearance on 2021-09-03 under 510(k) number K210940. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LuxaPrint Ortho Plus?

LuxaPrint Ortho Plus is a medical device that received FDA 510(k) clearance on 2021-09-03. The listed applicant is Dmg Digital Enterprises SE. The 510(k) number is K210940.

When did LuxaPrint Ortho Plus receive FDA 510(k) clearance?

LuxaPrint Ortho Plus received FDA 510(k) clearance on 2021-09-03, under 510(k) number K210940.

Who is the listed applicant for LuxaPrint Ortho Plus?

The FDA 510(k) record lists Dmg Digital Enterprises SE as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LuxaPrint Ortho Plus?

The FDA product code for LuxaPrint Ortho Plus is MQC.

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 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.