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

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 24, 2017

Den-mat Holdings, LLC Helen Ragus Regulatory Specialist 1017 W. Central Avenue Lompoc, California 93436

Re: K162967

Trade/Device Name: Nuance UNIVERSAL Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: January 5, 2017 Received: January 5, 2017

Dear Helen Ragus:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Susan Runno DDS, MA

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name nuance® UNIVERSAL

Indications for Use (Describe)

Direct restorations of anterior or posterior teeth (Class I - Class V)
Diastema closures
Intraoral repairs of fractured crowns/bridges

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for DenMat, a dental supply company. The logo features the letters "dm" in a stylized font, with the "d" in a light blue color and the "m" in a darker blue. Below the letters "dm" is the word "DenMat" in a smaller, darker blue font. The logo is simple and modern, and it is likely used on the company's website, marketing materials, and products.

1017 West Central Avenue Lompoc, CA 93436 805-346-3700 www.denmat.com

510(k) SUMMARY V.

Submitter:

Owner's Name:

1017 W. Central Avenue Address: Lompoc, CA 93436 U.S.A. . Phone Number: 805 346 3700 805 347 7940 Fax Number: Contact Person: Helen Ragus Regulatory Specialist 805 346 3700, X2932 hragus@denmat.com October 21, 2016 Date of Summary Preparation: Device Name: nuance® UNIVERSAL Trade Name: Light-Curable Dental Restorative Common Name: Material Material, Tooth Shade Resin Classification Name: (21 CFR 872.3690)

Den-Mat Holdings, LLC

Predicate Devices:

KURARAY MEDICAL INC.	K063595	CLEARFIL MAJESTY
		Posterior

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Description of the Device

Trade Name (Proprietary Name)	ModelNumbers
nuance® UNIVERSAL A1 – Syringe, 4.0 grams	CR1101
nuance® UNIVERSAL A2 – Syringe, 4.0 grams	CR1102
nuance® UNIVERSAL A3 – Syringe, 4.0 grams	CR1103
nuance® UNIVERSAL A3.5 – Syringe, 4.0 grams	CR1104
nuance® UNIVERSAL B1 – Syringe, 4.0 grams	CR1108
nuance® UNIVERSAL B2 – Syringe, 4.0 grams	CR1109
nuance® UNIVERSAL C3 – Syringe, 4.0 grams	CR1112
nuance® UNIVERSAL BL – Syringe, 4.0 grams	CR1106
nuance® UNIVERSAL OA2 – Syringe, 4.0 grams	CR1121
nuance® UNIVERSAL Dentin 1 - Syringe, 4.0 grams	TBD
nuance® UNIVERSAL Dentin 2 - Syringe, 4.0 grams	TBD
nuance® UNIVERSAL A1 – 16 X 0.35 gram singule	CR1135
nuance® UNIVERSAL A2 – 16 X 0.35 gram singule	CR1136
nuance® UNIVERSAL A3 – 16 X 0.35 gram singule	CR1137
nuance® UNIVERSAL A3.5 – 16 X 0.35 gram singule	CR1138
nuance® UNIVERSAL B1 – 16 X 0.35 gram singule	CR1142
nuance® UNIVERSAL B2 – 16 X 0.35 gram singule	CR1143
nuance® UNIVERSAL C3 – 16 X 0.35 gram singule	CR1146
nuance® UNIVERSAL BL - 16 X 0.35 gram singule	CR1140
nuance® UNIVERSAL OA2 – 16 X 0.35 gram singule	CR1155
nuance® UNIVERSAL Dentin 1 – 16 X 0.35 gram singule	TBD
nuance® UNIVERSAL Dentin 2 – 16 X 0.35 gram singule	TBD

Intended Use of the Device

nuance® UNIVERSAL is intended to be used as a composite tooth restorative.

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Indications for Use of the Device

nuance® UNIVERSAL is recommended for the following types of applications:

1. Direct restorations of anterior or posterior teeth (Class I Class V)
1. Diastema closures
1. Intraoral repairs of fractured crowns/bridges

Substantial Equivalence Discussion

1. Intended Uses/Indications for Use
  nuance® UNIVERSAL and the predicate device CLEARFIL MAJESTY Posterior are both intended to be used as a composite tooth restorative.

nuance® UNIVERSAL and the predicate device CLEARFIL MAJESTY Posterior are recommended for the following types of applications: direct restorations of anterior or posterior teeth (Class I - V), diastema closures and intra-oral repairs of fractured crowns and bridges.

The intended uses and indications for use of the subject device are substantially equivalent to that of the predicate device.

1. Chemical Components/Safety
  Chemical components in nuance® UNIVERSAL are used in the predicate device. The difference between nuance UNIVERSAL and the predicate device is limited to a slight formulation change - the predicate device uses titanium dioxide as the sole white pigment/opaquer used in color adjustment of the final device. In addition to titanium dioxide. nuance® UNIVERSAL contains zinc oxide as a partial replacement for the white pigment/opaque. This change does not raise different questions of safety and effectiveness than the predicate device. The predicate device has not been a focus of any advisory notice or recalls according to the post-market adverse event reporting requirements in the United States. The conclusion can be made that the safety of the subject device is substantially equivalent to that of the predicate device.

Technological Characteristics/Effectiveness and Performance

nuance UNIVERSAL and the predicate device CLEARFIL MAJESTY Posterior were both tested according to the applicable FDA recognized standard ISO 4049 Dental --polymer based restorative materials. This standard specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of cavities in the teeth and for luting. The difference between nuance® UNIVERSAL and the predicate device is limited to a slight formulation change - the predicate device uses titanium dioxide as the sole white

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pigment/opaquer used in color adjustment of the final device. In addition to titanium dioxide, nuance® UNIVERSAL contains zinc oxide as a partial replacement for the white pigment/opaque. This change does not raise different questions of safety and effectiveness than the predicate device. Testing results indicate that nuance® UNIVERSAL was as effective and performs as good as the predicate device. The conclusion can be made that the effectiveness and performance of the subject device is substantially equivalent to that of the predicate device.

Biocompatibility

According to ISO 10993 Biological Evaluation and Biocompatibility Testing of Medical Devices Part 1: Evaluation and testing within a risk management process, the subject device is categorized as an external communicating device with contact to tissue/bone/dentin and is a permanent contact device. nuance UNIVERSAL's chemical composition as well as materials and technological properties is substantially equivalent to that of the predicate device. Both devices are made of materials with a long history of safe use. Biocompatibility of the predicate device was established according to an evaluation of chemical ingredients of the devices used as predicates for its premarket notification. nuance UNIVERSAL's materials are used in the predicate device with the same type and duration of patient contact. These materials have been used in the dental industry for several decades, and therefore, a history of safe use. In addition to nuance UNIVERSAL's biocompatibility substantial equivalence to the predicate device, DenMat has submitted the materials for cytotoxicity test according to ISO 10993 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity with the conclusion that. "the test article was not considered to have a cytotoxic effect (no reactivity)". Test Report 16H0658S-M01 Cytotoxicity is provided in Attachment L. The predicate device has not been a focus of any advisory notice or recalls according to the post-market adverse event reporting requirements in the United States. Available studies from scientific literatures further support the biocompatibility of nuance® UNIVERSAL.

ISO-4049 Dental --- polymer-based restorative materials: Test Results
	Requirement	nuance®UNIVERSAL	CLEARFILMAJESTYPosterior
Sensitivity to ambientlight	>60 seconds, no cure	pass	pass
Depth of cure	> 0.5 mm	5.588	5.550
Flexural strength	>80 Mpa	98.7 Mpa	83.4Mpa
Water sorption/solubility	≤ 40 micrograms/mm^3	23.3/2.8	24.9/2.7
Shade/color stability	match standard	match/pass	match/pass
Radio opacity	≥ 1.0 mm aluminum	2 mm	2 mm

Comparative Performance Data

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Product	510(k)	Dental Applications*	ChemicalComposition	MaterialProperties
nuance®UNIVERSAL		- direct restorations ofanterior or posteriorteeth- diastema closures- intra-oral repairs offractured crowns andbridges	- Light-cure- Methacrylateresin based- Whitepigment/opaquer/anti-bacterial agent	- accurate colormatching- resistance toabrasion- high strength- polishable- radiopaque
CLEARFILMAJESTYPosterior	K063595	- direct restorations ofanterior or posteriorteeth- diastema closures- intra-oral repairs offractured crowns andbridges	- Light-cure- Methacrylateresin based- Whitepigment/opaquer	- accurate colormatching- resistance toabrasion- high strength- polishable- radiopaque

Summary of Features and Characteristics of the Device Compared to the Predicate Device:

- All listed Dental Applications are commonly used dental restorative material applications.

Device Risks and Recommended Mitigation Measures
Identified Risks	Recommended Mitigation

Identified Risks	Recommended Mitigation Measures
Mechanical Failure	Composition and physical propertyspecifications
Toxicity and Adverse Tissue Reaction	Biocompatibility
Improper Use	Device labeling

Conclusion

The information provided in this 510(k) submission demonstrates that nuance® UNIVERSAL is substantially equivalent to the predicate device CLEARFIL MAJESTY Posterior in terms of intended use, indications for use, chemical composition and physical properties.

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.