Class III and V restorations o
Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
Base/liner under direct restorations .
Repair of small defects in esthetic indirect restorations ●
Pit and fissure sealant ●
. Undercut blockout
Repair of resin and acrylic temporary materials o

Device Description

Nanova™ Flowable Dental Composite is a methacrylate based, low viscosity, visible-light activated, radiopaque, flowable composite. This device is available in syringe and ampule packaging. Nanova™ Flowable Dental Composite is available in a variety of tooth colored shades. Nanova™ Flowable Dental Composite contains methacrylate resins, photo-initiator, and inorganic filler material. Inorganic filler loading is approximately 60% by weight.

When irradiated by light, the methacrylate functionalities of the resins and surface-treated fillers undergo, in conjunction with the photo-initiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.

Nanova™ Flowable Dental Composite formulation is based off of several FDA cleared commercially available flowable dental composites. The formulation was modified to improve physical properties, such as flexural strength, and handling properties. As a result of the reformulation, a biocompatibility assessment was developed for Nanova™ Flowable Dental Composite using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines, including ISO 10993 Parts 3, 5, 6, 10 and 11.

AI/ML Overview

The document describes the Nanova™ Flowable Dental Composite, a dental material. The acceptance criteria and supporting studies are detailed, primarily through comparison with a predicate device and non-clinical performance testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for "Nanova™ Flowable Dental Composite" are largely established by demonstrating its substantial equivalence to a legally marketed predicate device (Filtek Supreme Ultra Flowable Restorative K100235) and by meeting established international and ADA standards for dental materials.

Acceptance Criteria (Standard / Predicate Comparison)	Reported Device Performance (Nanova™ Flowable Dental Composite)
Indications for Use: Same as predicate device.	Same as predicate device.
Composition: Methacrylate resins, photo-initiators, inorganic fillers.	Methacrylate resins, photo-initiators, inorganic fillers.
Flexural Strength: ISO 4049:2009 (E)	ISO 4049:2009 (E) (Passed / Met standard, comparison to predicate shows "Same")
Polymerization Method: Halogen and LED for 20s with minimum intensity 400 mW/cm² in the 400-500 nm range.	Halogen and LED for 20s with minimum intensity 400 mW/cm² in the 400-500 nm range.
Compressive Strength: ADA specification 27	ADA specification 27 (Passed / Met standard, comparison to predicate shows "Same")
Shrinkage Stress: Indiana University School of Dentistry method.	Nanova less stress (Improved compared to predicate).
Depth of Cure: ISO 4049: 2009 (E)	Both Pass (Met standard, comparison to predicate shows "Both Pass")
Microtensile Strength: Internal Testing method.	Nanova Stronger (Improved compared to predicate).
Water Sorption: ISO 4049:2009 (E)	Nanova Less absorption (Improved compared to predicate).
Water Solubility: ISO 4049:2009 (E)	Same (Met standard, comparison to predicate shows "Same")
Packaging: Syringe and Ampule.	Syringe and Ampule.
Biocompatibility: ISO 10993 Parts 3, 5, 6, 10, 11	Biocompatible based on assessment conducted.

Specific quantitative values for performance (e.g., exact flexural strength in MPa) are not provided in this summary, but the document confirms that the device meets or exceeds the standards or predicate device performance for these properties.

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

The document does not specify the sample sizes used for the individual non-clinical performance tests (e.g., number of specimens for flexural strength, depth of cure). It lists the types of tests performed.

The data provenance is from non-clinical benchtop testing performed by Nanova Biomaterials, Inc. and potentially external labs for GLP studies, but specific country of origin for all data is not explicitly stated. The submission is from Nanova Biomaterials, Inc. in Columbia, Missouri, USA. The studies are retrospective as they were conducted to support the 510(k) submission.

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

This information is not applicable as the studies are entirely non-clinical (benchtop and biocompatibility). There is no "ground truth" derived from expert consensus on patient data. The ground truth for performance is the specified standards (e.g., ISO, ADA) and comparison to the predicate device. For biocompatibility, it's defined by the ISO 10993 series.

4. Adjudication Method for the Test Set

This is not applicable as there is no human interpretation or subjective assessment of the test results that would require adjudication in the context of clinical or image-based studies. The results are quantitative measurements against established standards.

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

This is not applicable. The device is a dental restorative material, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

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

This is not applicable. The device is a physical dental material, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Nanova™ Flowable Dental Composite is primarily:

Established industry standards: ISO 4049:2009 (E) for properties like flexural strength, depth of cure, water sorption/solubility; ADA specification 27 for compressive strength.
Comparison to a legally marketed predicate device: Filtek Supreme Ultra Flowable Restorative (K100235) for various technical and performance characteristics.
Biocompatibility standards: ISO 10993 Parts 3, 5, 6, 10 and 11.

There is no pathology, outcomes data, or expert consensus on clinical cases described in this summary for establishing ground truth.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical material, not a machine learning model, therefore there is no "training set."

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

This is not applicable as there is no training set for this type of device.

Summary

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

June 18, 2015

Nanova Biomaterials, Inc. Mr. Andrew Ritts Senior Research Scientist 3806 Mojave Ct Columbia, Missouri 65202

Re: K150623

Trade/Device Name: Nanova Flowable Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: II Product Code: EBF Dated: May 6, 2015 Received: May 12, 2015

Dear Mr. Ritts:

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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Nanova Biomaterials, Inc. Nanova™ Flowable Dental Composite Dental Composite 510(k) Notification

Section 4. Indications for Use Statement

(As Required by 21 CFR 807.87(e))

510(k) Number (if known): K150623

Device Name: Nanova™ Flowable Dental Composite

Indications for Use:

Class III and V restorations o
Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
Base/liner under direct restorations .
Repair of small defects in esthetic indirect restorations ●
Pit and fissure sealant ●
. Undercut blockout
Repair of resin and acrylic temporary materials o

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Section 5. 510(k) Summary

1. Submitted By: Nanova Biomaterials, Inc 3806 Mojave Ct Columbia, MO 65202 USA 573-875-6682

Contact Person:	Andrew Ritts	Phone: (573) 823-3114
Secondary Contact:	Liang Chen	Phone: (573) 239-8952
2)	Establishment Registration No.:	NA
3)	Date Prepared:	March 5, 2015
4)	Device Trade Name:	Nanova™ Flowable Dental Composite
5)	Device Common Name:	Flowable Dental Composite
6)	Device Classification Name:	Material, Tooth Shade, Resin
7)	Classification Panel:	Dental
8)	Device Class:	Class II

1. Predicated Devices: Nanova™ Flowable Dental Composite is believed to be substantially equivalent to the following marketed products: Filtek Supreme Ultra Flowable Restorative (K100235) product code EBF manufactured by 3M ESPE.

10) Indication for Use:

Class III and V restorations
Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
Base/liner under direct restorations
Repair of small defects in esthetic indirect restorations ●
Pit and fissure sealant ●
Undercut blockout
Repair of resin and acrylic temporary materials ●

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Section 5. 510(k) Summary - Cont.

1. Device Description:
  Nanova™ Flowable Dental Composite is a methacrylate based, low viscosity, visible-light activated, radiopaque, flowable composite. This device is available in syringe and ampule packaging. Nanova™ Flowable Dental Composite is available in a variety of tooth colored shades. Nanova™ Flowable Dental Composite contains methacrylate resins, photo-initiator, and inorganic filler material. Inorganic filler loading is approximately 60% by weight.

1. Substantial Equivalence:
  The document, "Guidance on the CDRH Premarket Notification Review Program, 6/30/86 (K86-3)" was used to determine substantial equivalence:

a) The applicant device has the same intended use as the 510(k) cleared predicate listed above.

b) The technological characteristics of this product are believed to be substantially equivalent as those for the predicate device and other methacrylate based products currently on the market. Table 5.1 below shows a comparison of Nanova™ Flowable Composite and the predicate.

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Section 5. 510(k) Summary - Cont.

Table 5.1. Technical Comparison of Nanova™ Flowable Dental Composite and Filtek
Supreme Ultra Flowable Restorative (K100235).

Name	Nanova™ Flowable DentalComposite	Filtek Supreme Ultra FlowableRestorative (K100235)	Comparison
Indications foruse	Class III and V restorationsRestoration of minimallyinvasive cavity preparations(including small, non stress-bearing occlusalrestorations)Base/liner under directrestorationsRepair of small defects inesthetic indirect restorationsPit and fissure sealantUndercut blockoutRepair of resin and acrylictemporary materials	Class III and V restorationsRestoration of minimallyinvasive cavity preparations(including small, non stress-bearing occlusal restorations)Base/liner under directrestorationsRepair of small defects inesthetic indirect restorationsPit and fissure sealantUndercut blockoutRepair of resin and acrylictemporary materials	Same
Composition	Methacrylate resins, photo-initiators, inorganic fillers	Methacrylate resins, photo-initiators, inorganic fillers	Same
FlexuralStrength	ISO 4049:2009 (E)	ISO 4049:2009 (E)	Same
PolymerizationMethod	Halogen and LED for 20swith minimum intensity 400mW/cm² in the 400-500 nmrange	Halogen and LED for 20s withminimum intensity 400mW/cm² in the 400-500 nmrange	Same
CompressiveStrength	ADA specification 27	ADA specification 27	Same
ShrinkageStress	Indiana University School ofDentistry	Indiana University School ofDentistry	Nanova lessstress
Depth of Cure	ISO 4049: 2009 (E)	ISO 4049: 2009 (E)	Both Pass
MicrotensileStrength	Internal Testing	Internal Testing	NanovaStronger
Water Sorption	ISO 4049:2009 (E)	ISO 4049:2009 (E)	Nanova Lessabsorption
WaterSolubility	ISO 4049:2009 (E)	ISO 4049:2009 (E)	Same
Packaging	Syringe and Ampule	Syringe and Ampule	Same

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Section 5. 510(k) Summary - Cont.

1. Non-Clinical Performance Testing:
  Non-clinical and biological testing was completed to assess its performance and biocompatibility to support substantial equivalence. The data provided in this 510(k) submission shows that the composition is biocompatible based on the biocompatibility assessment conducted based on ISO 10993 and benchtop assessment based on UCM071631, ADA specification 27, and ISO 4049.

		Table 5.2 List of Tests Completed on Nanova™ Flowable Composite
--	--	-----------------------------------------------------------------	--

Name
Radiopacity Evaluation
Color Stability Test
Compressive Strength
Depth of Cure
Double Bond Conversion (Degree of Conversion)
Flexural Strength
Knoop Hardness
Microtensile Strength
Sensitivity to Ambient Light
Shelf Life Depth of Cure
Shelf Life Flexural Strength
Water Sorption and Solubility
Custom Acute Systemic Injection
ISO Agarose Overlay Using L-929 Mouse Fibroblast Cells (GLP)
ISO Intracutaneous Irritation Test (GLP-2 Extracts)
ISO Guinea Pig Maximization Sensitization Test (GLP-2 Extracts)
ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP)

1. Clinical Performance Testing: Clinical performance data was not included.

Conclusion:

Nanova Biomaterials Inc. believes that Nanoval™ Flowable Dental Composite is substantially equivalent to currently legally marketed products. It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or safety risks.

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.