nuance® FLOW is a Class II medical device intended to be used as a composite tooth restorative. 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® FLOW is DenMat's Flowable for use 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, esthetic restoration. It is a lower viscosity material that allows it to be used when ease of application and thinner layers are needed. nuance® Flow may be appropriate for dental Class I, III, IV and V type restorations where maximum mechanical strength and wear resistance is not required. A small amount of fluoride (.5-.7%) is included to minimize likelihood of secondary caries. nuance® FLOW is packaged in a 1 mL single• barrel syringe and offered in 8 shades: A1, A2, A3, A3.5, B1, B2, BL1 and BL2.

AI/ML Overview

This document describes the 510(k) premarket notification for the nuance® FLOW dental restorative material, and its substantial equivalence to the predicate device LC FLOWFILL.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Test (ISO 4049 Std.)	Acceptance Criteria (Requirement)	nuance® FLOW Performance	LC FLOWFILL Performance (Predicate)
Film thickness	< 50 micron	37.8 micron	40.5 micron
Sensitivity to ambient light	> 60 seconds, no cure	pass	Pass
Depth of cure	> 0.5mm	2.49 mm	2.55 mm
Flexural strength	> 50 Mpa	85.9 Mpa	79.0 Mpa
Water sorption/solubility	< 40 micrograms/mm³	27.2 micrograms/mm³	25.9 micrograms/mm³
Shade/color stability	match standard	match/pass	match/pass
Radio opacity	> 1.0mm aluminum	3mm aluminum	2mm aluminum

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each test performed on nuance® FLOW or LC FLOWFILL. It only states that "Testing results indicate that nuance® FLOW was as effective and performs as good as the predicate device."

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, given that it's a 510(k) submission to the FDA, it is expected that the tests were conducted according to recognized international standards (ISO 4049) which implies controlled laboratory settings. The document also mentions "Scientific literature have been evaluated to support the use of similar products for the same indications," suggesting some reliance on existing published data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests are bench tests based on an international standard (ISO 4049), not clinical evaluations requiring expert interpretation of results for ground truth.

4. Adjudication method for the test set

This information is not applicable as the tests are objective, quantitative measurements against a standard, not subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study and no mention of AI assistance. This device is a dental restorative material, not an AI-powered diagnostic tool.

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

This question is not applicable as the device is a physical dental material and not an algorithm.

7. The type of ground truth used

The ground truth used for performance evaluation is based on the objective measurement criteria defined in the ISO 4049 standard for "Dentistry – Polymer-based restorative materials." This standard sets specific quantitative thresholds for various material properties.

8. The sample size for the training set

This information is not applicable as the device is a chemical material, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable as the device is a chemical material, not a machine learning algorithm.

Summary

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

May 1, 2015

Den-Mat Holdings, LLC Ms. Helen Ragus Regulatory Specialist 1017 W. Central Avenue Santa Maria, CA 93436

Re: K143679

Trade/Device Name: nuance® FLOW Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: March 31, 2015 Received: April 1, 2015

Dear Ms. 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.

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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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Tina
Kiang -S

for Erin I. Keith, M.S. 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

510(k) Number (if known)

Device Name

nuance® FLOW

Indications for Use (Describe)

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

Direct restorations of anterior or posterior teeth
Cavity base/liner
Intraoral repairs of fracture crowns/bridges

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

☑ Registration Use (Part 21 CFR 601 Subpart D)	☐ One-Time Study Use (21 CFR 601 Subpart C)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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

K143679

510(k) SUMMARY

S&C Polymer GmbH

Submitter:

Owner's Name:	Den-Mat Holdings, LLC
Address:	1017 W. Central AvenueLompoc, CA 93436U.S.A.
Phone Number:	805 346 3700
Fax Number:	805 347 7940
Contact Person:	Helen RagusRegulatory Specialist805 346 3700, X2932hragus@denmat.com
Date of SummaryPreparation:	April 30, 2015
Device Name:
Trade Name:	nuance® FLOW
Common Name:	Light-Curable Dental RestorativeMaterial
Classification Name:Classification Number:	Material, Tooth Shade ResinClass II (21 CFR 872.3690)
Product Code	EBF
Predicate Device:
	K990108

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Description of the Device

Intended Use of the Device

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

Indications for Use of the Device

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

1. Direct restorations of anterior or posterior teeth
1. Cavity base/liner
1. Intraoral repairs of fracture crowns/bridges

Substantial Equivalence Discussion

1. Intended Uses/Indications for Use
  nuance® FLOW and the predicate device LC FLOWFILL are both intended to be used as a composite tooth restorative.

nuance® FLOW and the predicate device LC FLOWFILL are recommended for the following types of applications: direct restorations of anterior or posterior teeth, in cavity liner/base and intra-oral repairs of fractured crowns and bridges.

Scientific literature have been evaluated to determine the equivalence of similar products used for the same indications. The intended uses and indications for use of the subject device are substantially equivalent to that of the predicate device.

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2) Chemical Components

Chemical components in nuance® FLOW are used in the predicate device. Scientific literature have been evaluated to support the use of similar products for the same indications. 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 chemical composition of the subject device is substantially equivalent to that of the predicate device.

3) Technological Characteristics and Performance

nuance® FLOW and the predicate device LC FLOWFILL 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. Testing results indicate that nuance® FLOW was as effective and performs as good as the predicate device. In addition, scientific literature was evaluated to support the use of similar products for the same indications. The conclusion can be made that the technological characteristics and performance of the subject device are substantially equivalent to that of the predicate device.

Biocompatibility

The subject device is categorized as an external communicating device with contact to tissue/bone/dentin and is a permanent contact device. nuance® FLOW'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 EN 30993 and ISO 10993 Biological evaluation of medical devices. Cytotoxicity study resulted in no signs of cytotoxicity observed. Examination of irritation revealed no intracutaneous reactivity. 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 support the biocompatibility of nuance® FLOW. No biocompatibility test is required to establish substantial equivalence.

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Comparative Performance Data

IS0-4049 Dental--- polymer-based restorative materials: Test Results
		nuance™	LC
	Requirement	FLOW	FLOWFIL
Film thickness	<50 micron	37.8 micron	40.5 micron
Sensitivity to ambient
light	>60 seconds, no cure	pass	Pass
Depth of cure	>0.5mm	2.49	2.55
Flexural strength	>50Mpa	85.9 Mpa	79.0Mpa
	<40
Water sorption/solubility	micrograms/mm3	27.2	25.9
Shade/color stability	match standard	match/pass	match/pass
Radio opacity	>1.0mm mm aluminum	3mm	2mm

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

Product	510(k)	Dental Applications*	Chemical Composition	Material Properties
nuance® Flow	K143679	- direct restorations of anterior or posterior teeth- in cavity liner/base- intra-oral repairs of fractured crowns and bridges	-Light-cure-Methacrylate resin based-Contains fluoride	-excellent color stability- resistance to abrasion-high strength-high gloss polishability-radiopaque
LC FLOWFILL	K990108	- tooth fillings- sealings-cementing(Current terminology used for the submission application)	-Light-cure-Methacrylate resin based-Contains fluoride	-excellent color stability- resistance to abrasion-high strength-high gloss polishability- radiopaque

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

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Conclusion

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

It is concluded that the information supplied in this submission has proven the substantial equivalence of this product.

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.