Cleared Traditional

K210940 - LuxaPrint Ortho Plus

K210940 · Dmg Digital Enterprises SE · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
158d
Days
-
Risk

K210940 is an FDA 510(k) clearance for the LuxaPrint Ortho Plus. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Dmg Digital Enterprises SE (Hamburg, DE). The FDA issued a Cleared decision on September 3, 2021 after a review of 158 days - an extended review cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dmg Digital Enterprises SE devices

FDA 510(k) Submission Details - K210940

510(k) Number K210940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2021
Decision Date September 03, 2021
Days to Decision 158 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 127d · This submission: 158d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Consultant

Delphi Medical Device Consulting, Inc.
Pamela Papineau

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQC Mouthguard, Prescription

All 42
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K210940.
SleepRight Select-Comfort Dental Guard
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JS Dental Lab Mouth Guard
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Panthera Occlusal Appliance
K203596 · Panthera Dental, Inc. · Apr 2021
KeyPrint KeySplint Hard
K203000 · Mycone Dental Supply Co. Inc. (Dba Keystone Industries) · Apr 2021