Nanova™ Universal Dental Composite is a methacrylate based, visible-light activated, radiopaque, universal composite. This device is available in twist syringe and ampule packaging. Nanova™ Universal Dental Composite is available in a variety of tooth colored shades. Nanova"™ Universal Dental Composite contains methacrylate resins, photo-initiator, and inorganic filler material. Inorganic filler loading is approximately 77% 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™ Universal Dental Composite formulation is based off of several FDA approved commercially available universal 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™ Universal Dental Composite using standard risk assessment techniques and consideration of FDA & International Standards, including ISO 10993 Parts 5 and 10.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria with pass/fail thresholds for each test in a table format. Instead, it indicates that the device "Passed" each test, implying that it met the (unspecified) acceptance criteria for those tests. It also compares the device's performance to the predicate device in a qualitative manner for some properties.

Acceptance Criteria (Implied)	Reported Device Performance (Nanova™ Universal Dental Composite)
Meets ISO 4049 requirements (Flexural Strength)	> 100 MPa (Consistent with predicate)
Meets ADA specification 27 (Compressive Strength)	> 300 MPa (Consistent with predicate)
Passes ISO 4049:2009(E) (Depth of Cure)	Passed
Meets ISO 4049:2009(E) (Water Sorption)	Less Adsorption (Compared to predicate)
Meets ISO 4049:2009(E) (Water Solubility)	Less Solubility (Compared to predicate)
Biocompatible (ISO 10993 Parts 5 and 10)	Passed all biocompatibility tests (Cytotoxicity, irritation, sensitization)
Radiopacity Evaluation	Passed
Color Stability	Passed
Microtensile Strength	Passed
Knoop Hardness	Passed
Double Bond Conversion (Degree of Conversion)	Passed
Shelf life	Passed
Surface Gloss	Passed
Surface Roughness	Passed

Study Details

The provided document describes a non-clinical performance testing study.

Sample size used for the test set and the data provenance: Not explicitly stated. The tests are benchtop assessments using standardized methods (ISO standards, ADA specifications). The provenance of the data is from Nanova Biomaterials, Inc.'s own testing. No specific country of origin for the data is mentioned beyond Nanova Biomaterials, Inc. being a US-based company. The study is retrospective in the sense that the data was collected prior to the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was non-clinical benchtop testing, not involving human interpretation or ground truth establishment by experts in that sense.
Adjudication method for the test set: Not applicable. This was non-clinical benchtop testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states: "Clinical performance data was not included."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a material device, not an AI algorithm.
The type of ground truth used: For the physical and mechanical properties, the "ground truth" or reference was established by the specified international standards (ISO 4049, ADA specification 27) and FDA guidance (UCM071576, UCM071631). For biocompatibility, the ground truth was based on ISO 10993 standards. The results (e.g., strength values, pass/fail for biocompatibility) are directly from laboratory measurements against these established standards.
The sample size for the training set: Not applicable. This is not an AI/machine learning device. The product formulation was "modified to improve physical properties," which would involve research and development, but not a "training set" in the context of AI.
How the ground truth for the training set was established: Not applicable. (See above).

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a human face in profile, with three overlapping profiles to represent the department's focus on health, human services, and the well-being of the nation. The seal is black and white.

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

November 17, 2015

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

Re: K152004

Trade/Device Name: Nanova™ Universal Dental Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: II Product Code: EBF Dated: October 12, 2015 Received: October 19, 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 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/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 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 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™ Universal 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): K152004

Device Name: Nanova 204 Universal Dental Composite

Indications for Use:

Nanova Universal Dental Composite is indicated for use in:

· Direct anterior and posterior restorations (including occlusal surfaces)
Core Build-ups
· Splinting
· Indirect restorations including inlays, onlays and veneers

Prescription Use X X

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 F NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Nanova Biomaterials, Inc. Nanova™ Universal Dental Composite Dental Composite K152004

Section 5. 510(k) Summary

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

	Contact Person: Andrew RittsSecondary Contact: Liang Chen	Phone: (573) 823-3114Phone: (573) 239-8952
2)	Establishment Registration No.:	3011430871
3)	Date Prepared:	October 12, 2015
4)	Device Trade Name:	Nanova™ Universal Dental Composite
5)	Device Common Name:	Universal Dental Composite
6)	Device Classification Name:	Material, Tooth Shade, ResinProduct code: EBF, Reg. #: 872.3690
7)	Classification Panel:	Dental
8)	Device Class:	Class II

1. Predicate Devices: Nanova™ Universal Dental Composite is believed to be substantially equivalent to the following marketed products: Filtek Supreme Ultra Universal Restorative (K083610) product code EBF manufactured by 3M ESPE.

10) Indication for Use: Nanova Universal Dental Composite is indicated for use in:

Direct anterior and posterior restorations (including occlusal surfaces)
Core Build-ups
Splinting ●
. Indirect restorations including inlays, onlays and veneers

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Nanova Biomaterials, Inc. Nanova™ Universal Dental Composite Dental Composite K152004

Section 5. 510(k) Summary - Cont.

1. Device Description:
  Nanova™ Universal Dental Composite is a methacrylate based, visible-light activated, radiopaque, universal composite. This device is available in twist syringe and ampule packaging. Nanova™ Universal Dental Composite is available in a variety of tooth colored shades. Nanova"™ Universal Dental Composite contains methacrylate resins, photo-initiator, and inorganic filler material. Inorganic filler loading is approximately 77% 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 NanovaTM Universal Dental Composite and Filtek Supreme Ultra Universal Restorative (K083610)

Name	Nanova™ Universal Dental Composite	Filtek Supreme Ultra Universal Restorative (K083610)	Comparison
Indications for use	Direct anterior and posterior restorations (including occlusal surfaces)Core Build-upsSplintingIndirect restorations including inlays, onlays and veneers	Direct anterior and posterior restorations (including occlusal surfaces)Core Build-upsSplintingIndirect restorations including inlays, onlays and veneers	Indicated for the same purposes
Composition	Methacrylate resins, photo-initiators, inorganic fillers	Methacrylate resins, photo-initiators, inorganic fillers	Chemistries are similar
Flexural Strength	ISO 4049:2009 (E)	ISO 4049:2009 (E)	Both above 100 MPa
Compressive Strength	ADA specification 27	ADA specification 27	Both above 300 MPa
Depth of Cure	Passes ISO 4049:2009(E)	Passes ISO 4049:2009(E)	Passed
Water Sorption	ISO 4049:2009 (E)	ISO 4049:2009 (E)	Nanova Less Adsorption
Water Solubility	ISO 4049:2009 (E)	ISO 4049:2009 (E)	Nanova Less Solubility
Packaging	Twist Syringe and Ampule	Twist Syringe and Ampule	Both use twist syringe and ampules

Nanova™ Universal Dental Composite fulfilled ISO 4049 requirements as well as FDA 's guidance ucm071576 Dental Composite Resin Devices. The strength and physical properties show Nanova™ Universal Dental Composite performs equivalently to the predicate device. ISO 10993 biocompatibility (including cytotoxicity, irritation, and sensitization) confirms the material is biocompatible. The fulfillment of ISO 4049 and ISO 10993 show Nanova Universal Dental Composite is substantially equivalent to the predicate.

These differences do not affect the equivalence.

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Nanova Biomaterials, Inc. Nanova™ Universal Dental Composite Dental Composite K152004

13) 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. All biocompatibility tests completed were passed.

Name	Result
Radiopacity Evaluation	Passed
Color Stability	Passed
Flexural Strength	Passed
Compressive Strength	Passed
Depth of Cure	Passed
Microtensile Strength	Passed
Water Sorption and Solubility	Passed
Knoop Hardness	Passed
Double Bond Conversion (Degree of Conversion)	Passed
ISO Agarose Overlay Using L-929 Mouse Fibroblast Cells	Passed
ISO Intracutaneous Irritation Test	Passed
ISO Guinea Pig Maximization Sensitization Test	Passed
ISO MEM Elution Using L-929 Mouse Fibroblast Cells	Passed
Shelf life	Passed
Surface Gloss	Passed
Surface Roughness	Passed

Table 5.2 List of Tests Completed on Nanova™ Universal Composite

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

Conclusion:

Nanova Biomaterials Inc. believes that Nanova™ Universal 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 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.