FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

nuance® UNIVERSAL is a Class II medical device, under Classification 21 CFR 872.3690. Product Code EBF. intended to be used as a composite tooth restorative. The device falls within the scope of guidance document, "Dental Composite Resin Devices -Premarket Notification [510(k)] Submissions. According to the applicable FDA recognized consensus standard, ISO 4049 - "Dentistry - Polymer-based restorative materials, this device is classified as Class 2: materials whose setting is affected by the application of energy from an external source, such as blue light or heat (Group 2). nuance® UNIVERSAL is used in direct restorations of anterior or posterior teeth. They are polymerizable dental monomer resins that are chemically-cured when exposed to dental curing lights. It is used to form a durable, aesthetic restoration. It is a higher viscosity material to be used where mechanical strength is a primary importance. nuance® UNIVERSAL may be appropriate for dental Class I, II, III, IV and V type restorations. nuance® UNIVERSAL is packaged in a 4 gram single-barrel syringe, a 0.35 gram singules, and offered in 11 shades listed below:

AI/ML Overview

This document details the 510(k) submission for Nuance UNIVERSAL, a light-curable dental restorative material. The submission aims to prove substantial equivalence to a predicate device, CLEARFIL MAJESTY Posterior, rather than establishing acceptance criteria and proving performance through a clinical study as would be done for novel or high-risk devices.

Therefore, many of the requested details, such as sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of device submission, which relies on bench testing against recognized standards and comparison to a legally marketed predicate device with a history of safe use.

Here's the information that is available based on the provided text, structured as closely as possible to your request, with explicit notes for inapplicable sections:

Device: Nuance UNIVERSAL (Light-Curable Dental Restorative Material)

Study Focus: Substantial Equivalence to Predicate Device (CLEARFIL MAJESTY Posterior)

Type of Study Conducted: Bench Testing against ISO 4049 (Dental - Polymer-based restorative materials) and biocompatibility testing. This is not a clinical study involving human patients or an AI/algorithm-based device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the ISO 4049 standard, and the reported performance is compared against these and the predicate device.

Acceptance Criteria (ISO 4049 Requirement)	Nuance UNIVERSAL Reported Performance	Predicate Device (CLEARFIL MAJESTY Posterior) Reported Performance
Sensitivity to ambient light: >60 seconds, no cure	Pass	Pass
Depth of cure: > 0.5 mm	5.588 mm	5.550 mm
Flexural strength: >80 Mpa	98.7 Mpa	83.4 Mpa
Water sorption/solubility: ≤ 40 micrograms/mm^3	23.3 / 2.8 micrograms/mm^3	24.9 / 2.7 micrograms/mm^3
Shade/color stability: match standard	Match/Pass	Match/Pass
Radio opacity: ≥ 1.0 mm aluminum	2 mm	2 mm

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in terms of the number of samples for each test (e.g., how many specimens for flexural strength). The testing was conducted according to the ISO 4049 standard, which specifies the number of samples required for each test. This is bench testing, not a clinical test set from patient data.
Data Provenance: The data comes from in vitro (bench) testing performed by the manufacturer, Den-Mat Holdings, LLC. The location of the testing facility is not specified, but the company is based in Lompoc, California, USA. The data is prospective in the sense that the tests were performed to generate data for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. This device is a material, and its performance is evaluated through physical and chemical property testing against an international standard (ISO 4049) and comparison to a predicate device. Ground truth is established by objective measurements based on the standard, not expert consensus on interpretations of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not Applicable. See point 3. Testing involves objective measurements, not subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

No. This is not an AI/imaging device requiring an MRMC study. It is a dental restorative material.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This device does not involve an algorithm or AI.

7. The type of ground truth used

Objective measurement against an international standard (ISO 4049) and comparative data to a legally marketed predicate device.
Additionally, Biocompatibility was demonstrated through:
- Substantial equivalence to the predicate device, citing materials with a long history of safe use in dentistry.
- Specific in vitro cytotoxicity testing (ISO 10993 Part 5), with the conclusion "the test article was not considered to have a cytotoxic effect (no reactivity)."

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device that requires a training set. The device formulation is based on established dental material science principles and minor modifications to an existing predicate device.

9. How the Ground Truth for the Training Set was Established

Not Applicable. See point 8.

Summary

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.