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K Number
K230592
Device Name
LuxCreo Dental Night Guard Resin
Manufacturer
LuxCreo Inc.
Date Cleared
2024-01-18

(321 days)

Product Code
MQC,KMY
Regulation Number
N/A
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

LuxCreo Dental Night Guard Resin is a liquid light-curing resin product indicated for the creation of orthodontic and dental appliances such as mouthguards, splints, and repositioners.

Device Description

LuxCreo Dental Night Guard Resin is a liquid light-curing resin product.

AI/ML Overview

The provided text focuses on the FDA's 510(k) clearance for the "LuxCreo Dental Night Guard Resin" and does not contain information about acceptance criteria or a study proving device performance against those criteria. The document is an FDA clearance letter, which confirms that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.

Therefore, I cannot fulfill your request for:

  • A table of acceptance criteria and reported device performance
  • Sample size used, data provenance for the test set
  • Number of experts and their qualifications for ground truth
  • Adjudication method
  • MRMC comparative effectiveness study results
  • Standalone performance details
  • Type of ground truth used
  • Sample size for the training set
  • How ground truth for the training set was established

This information would typically be found in a separate clinical or non-clinical study report submitted as part of the 510(k) application, but it is not detailed in this FDA clearance letter.

N/A