Cleared Traditional

K210940 - LuxaPrint Ortho Plus (FDA 510(k) Clearance)

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

Submission Details

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.

Device Classification

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.

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