1. Base under Class I and II direct restorations
1. Liner under direct restorative materials
1. Pit and fissure sealant
1. Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
1. Class III and V restorations
1. Blocking out of undercuts
1. Repair of small enamel defects
1. Repair of small defects in esthetic indirect restorations
1. Repair of resin and acrylic temporary materials

As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown

Device Description

Novidia™ Bulk Fill Flow Composite is a low viscosity, visible-light activated, radiopaque, flowable composite indicated for minimally invasive cavity preparations as well as various other indications. The resin matrix of the Novidia™ Bulk Fill Flow Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA). The inorganic filler of the Novidia™ Bulk Fill Flow Composite is a mix of particles of alumino-silicate-based glasses, silica dioxide and pigments. A small percentage of the silica-based filler particles are covalently bound to quaternary ammonium residues (QASi), added to maintain the integrity of the restoration. The Novidia™ Bulk Fill Flow Composite is provided in syringes (2 g) and in single-dose capsules (0.2 g) and is available in two shades (A2 and A3).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental device, "Novidia™ Bulk Fill Flow Composite." The information focuses on demonstrating substantial equivalence to a predicate device ("Filtek™ Bulk Fill Flowable Restorative") primarily through non-clinical performance testing (bench testing and biocompatibility assessments).

Therefore, the requested information regarding acceptance criteria and the study that proves the device meets the acceptance criteria will reflect this focus on non-clinical, in vitro performance, rather than clinical study data involving human readers or AI algorithms.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for Novidia™ Bulk Fill Flow Composite are implicitly aligned with the performance characteristics of its predicate device, Filtek™ Bulk Fill Flowable Restorative, as well as the requirements of the ISO 4049:2009 standard for polymer-based restorative materials.

Feature	Acceptance Criteria (based on ISO 4049:2009 & Predicate)	Reported Device Performance (Novidia™ Bulk Fill Flow Composite)
Flexural Strength	≥80 MPa (met by predicate)	Met acceptance criteria (explicitly stated)
Radio-opacity	>1.0 mm Al (met by predicate)	Met acceptance criteria (explicitly stated)
Depth of Cure	≥2mm at an intensity of ≥ 550 mW/cm2 for 20 seconds (met by predicate)	Met acceptance criteria (explicitly stated)
Water Sorption	≤ 40 µg/mm3 (met by predicate)	Met acceptance criteria (explicitly stated)
Water Solubility	≤ 7.5 µg/mm3 (met by predicate)	Met acceptance criteria (explicitly stated)
Spontaneous Polymerization Sensitivity at Ambient Light	60 ± 5 sec. (physically homogenous by visual inspection) (met by predicate)	Met acceptance criteria (explicitly stated)
Intensity for Curing	Similar to predicate's range (400-1000 mW/cm²)	≥550 mW/cm²
Wavelength for Curing	Similar to predicate's range (400-500 nm)	430-490 nm
Curing Time	Similar to predicate's (20 sec; 40 sec for opaque shades)	20 sec.
Biocompatibility	Pass ISO 10993 and ISO 7405	Passed (stated to be biocompatible)
Other Bench Tests	Performs as intended	Performance assessed for Elastic modulus, Compression strength, Shade and color stability, Polymerization conversion degree, Viscosity, Knoop hardness, Preservation of Surface Integrity

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

The document does not specify the exact sample sizes (e.g., number of specimens tested for flexural strength) for the non-clinical bench tests. However, it indicates that testing was conducted "per ISO 4049 and FDA guidance document 'Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions'." These standards and guidance documents typically specify minimum sample sizes for material properties testing.

The data provenance is from non-clinical laboratory testing performed to support the 510(k) submission. No specific country of origin for the testing lab is mentioned, but the submitter, Nobio Ltd., is based in Kadima, Israel. This is retrospective in the sense that the testing was completed prior to the submission for regulatory clearance.

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

This question is not applicable in the context of this 510(k) submission. The "ground truth" for the device's performance is established by objective, standardized laboratory measurements against established international standards (ISO 4049:2009) and FDA guidance, not by expert consensus or human interpretation of images/data for diagnostic purposes.

4. Adjudication Method for the Test Set

Not applicable. This device is a material, and its performance is evaluated through physical and chemical property testing, not through human adjudication of diagnostic outcomes.

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

Not applicable. This device is a dental restorative material, not an AI-assisted diagnostic or imaging device. No MRMC study was performed or is relevant. The document explicitly states: "Animal and clinical performance data was not included." and "Clinical studies demonstrating that the presence of QASi in this device improves clinical outcomes have not been conducted."

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective, standardized measurements of its physical, chemical, and biological properties as defined by:

International standards (e.g., ISO 4049:2009 for polymer-based restorative materials, ISO 10993 for biocompatibility).
FDA guidance documents for dental composite resin devices.
Comparison to the established performance characteristics of the legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 12, 2019

Nobio Ltd. % Shoshana Friedman Regulatory Consultant ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, North Carolina 28269

Re: K182714

Trade/Device Name: Novidia™ Bulk Fill Flow Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: June 11, 2019 Received: June 12, 2019

Dear Shoshana Friedman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K182714

Device Name

Novidia™ Bulk Fill Flow Composite

Indications for Use (Describe)

The Novidia™ Bulk Fill Flow Composite is indicated for:

1. Base under Class I and II direct restorations
1. Liner under direct restorative materials
1. Pit and fissure sealant
1. Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
1. Class III and V restorations
1. Blocking out of undercuts
1. Repair of small enamel defects
1. Repair of small defects in esthetic indirect restorations
1. Repair of resin and acrylic temporary materials

As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown

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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510(K) SUMMARY [as required by section 807.92(c)] Novidia™ Bulk Fill Flow Composite 510(k) Number K182714

5.1 SUBMITTER

Applicant's Name:

Nobio Ltd. 8 Hamatechet St. POB 50502 Kadima, Israel 6092000 Phone: +972 3 9059966

Contact Person:

Shoshana (Shosh) Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: 704-430-8695 s.friedman@promedoss.com

Date Prepared:

July 12, 2019

5.2 DEVICE

Trade Name: Novidia™ Bulk Fill Flow Composite

Classification: Name: Tooth Shade Resin Material Product Code: EBF Regulation No: 872.3690 Class: 2 Review Panel: Dental

5.3 PREDICATE DEVICE

Filtek™ Bulk Fill Flowable Restorative, manufactured by 3M ESPE Dental Products, cleared under K120453 is the primary predicate device.

Additionally, we are using the following reference devices as examples of FDAcleared devices that incorporate quaternary ammonium in their formulation:

Clearfil Protect Bond cleared under K033938 ●
. Orthodontic Acrylic cleared under K141439 and Orthodontic Acrylic 2cleared under K163482.

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5.4 DEVICE DESCRIPTION

The resin matrix of the Novidia™ Bulk Fill Flow Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA).

The inorganic filler of the Novidia™ Bulk Fill Flow Composite is a mix of particles of alumino-silicate-based glasses, silica dioxide and pigments. A small percentage of the silica-based filler particles are covalently bound to quaternary ammonium residues (QASi), added to maintain the integrity of the restoration.

Note: "Clinical studies demonstrating that the presence of QASi in this device improves clinical outcomes have not been conducted".

The Novidia™ Bulk Fill Flow Composite is provided in syringes (2 g) and in singledose capsules (0.2 g) and is available in two shades (A2 and A3).

ર્ડ INDICATIONS FOR USE

Novidia™ Bulk Fill Flow Composite is indicated for:

1. Base under Class I and II direct restorations
1. Liner under direct restorative materials
1. Pit and fissure sealant
1. Restoration of minimally invasive cavity preparations (including small, nonstress-bearing occlusal restorations)
1. Class III and V restorations
1. Blocking out of undercuts
1. Repair of small enamel defects
1. Repair of small defects in esthetic indirect restorations
Repair of resin and acrylic temporary materials 9.
1. As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown

5.6 SUBSTANTIAL EQUIVALENCE

The Novidia™ Bulk Fill Flow Composite has the same indications as the Filtek™ Bulk Fill Flowable Restorative.

The technological characteristics of the Novidia™ Bulk Fill Flow Composite are substantially equivalent to these of the predicate device and other methacrylate-based products currently on the market. Table 5-1 below shows a comparison of Novidia™ Bulk Fill Flow Composite and the predicate device.

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Feature	Novidia™ Bulk Fill FlowComposite	Filtek Bulk FillFlowableRestorative	Comparison
510(k) Number	K182714	K120453	NA
Classification	EBF	EBF	Same
Indications	• Base under Class I and IIdirect restoration• Liner under direct restorativematerials• Pit and fissure sealant• Restoration of minimallyinvasive cavity preparations(including small, non-stress-bearing occlusal restorations)• Class III and V restorations• Blocking out of undercuts• Repair of small enamel defects• Repair of small defects inesthetic indirect restorations• Repair of resin and acrylictemporary materials• As a core build-up where atleast half the coronal toothstructure is remaining toprovide structural support forthe crown	• Base under Class I andII direct restorations• Liner under directrestorative materials• Pit and fissure sealant• Restoration of minimallyinvasive cavity preparations(including small, non-stressbearing occlusalrestorations)• Class III and V restorations• Undercut blockout• Repair of small enamel defects• Repair of small defects inesthetic indirectrestorations• Repair of resin andacrylic temporarymaterials• As a core build-up where atleast half the coronal toothstructure is remaining toprovide structural supportforthe crown	Same
Composition	Methacrylate resins, photo-initiators, inorganic fillers	Methacrylate resins,photo- initiators, inorganicfillers	Similar
Packaging	Syringe and single-dose capsule	Syringe and ampule	Same
FlexuralStrength	ISO 4049:2009	ISO 4049:2009	Both metacceptancecriteria of ≥80MPa
Intensity forcuring	$≥550 mW/cm²$	$400 -1000 mW/cm²$	Similar
Wavelength forcuring	430-490 nm	400-500 nm	Same
Curing time	20 sec.	Opaque shades 40 sec;All other shades 20	Same
Radio-opacity	ISO 4049: 2009	ISO 4049: 2009	Both metacceptancecriteria of >1.0mm Al
Depth of Cure	ISO 4049: 2009	ISO 4049: 2009	Both metacceptancecriteria of $\ge$ 2mmat an intensity of$\ge$ 550 mW/cm2 for20 seconds
Water Sorption	ISO 4049:2009	ISO 4049:2009	Both metacceptancecriteria of $\le$40 $\mu$ g/mm3
WaterSolubility	ISO 4049:2009	ISO 4049:2009	Both metacceptancecriteria of $\le$ 7.5$\mu$ g/mm3
SpontaneousPolymerizationSensitivity atAmbient Light	ISO 4049:2009	ISO 4049:2009	Both metacceptancecriteria of 60 $\pm$ 5sec. (physicallyhomogenous byvisual inspection)

Table 5-1: Comparison of Novidia™ Bulk Fill Flow Composite and Filtek™ Bulk Fill Flowable Restorative

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5.7 PERFORMANCE DATA

Non=Clinical Performance Testing:

Non-clinical and biological testing was completed to assess the performance and biocompatibility of the Novidia™ Bulk Fill Flow Composite and to support substantial equivalence. The data provided in this 510(k) submission shows that the composite is biocompatible based on the biocompatibility assessment conducted as per ISO 10993 and ISO 7405 and performs as intended based on the bench testing per ISO 4049 and FDA guidance document "Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions". The list of these tests is provided in Table 5-2.

Table 5-2: List of Tests Completed on Novidia™ Bulk Fill Flow Composite

Biocompatibility
Cytotoxicity
Oral Mucosal Irritation Test
Acute Systemic Toxicity
Material Mediated Pyrogenicity
Bacterial Reverse Mutation
Mouse Lymphoma Assay
Biological Risk Assessment
Bench Testing
Flexural strength
Elastic modulus
Compression strength
Shade and color stability
Polymerization conversion degree
Viscosity
Spontaneous polymerization sensitivity at ambient light
Water solubility
Water sorption
Depth of cure
Radio-opacity
Knoop hardness
Preservation of Surface Integrity

Animal and Clinical Performance Testing:

Animal and clinical performance data was not included.

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5.8 CONCLUSION

Nobio Ltd. believes that Novidia™ Bulk Fill Flow Composite is substantially equivalent to the Filtek™ Bulk Fill Flow Restorative and other legally marketed products.

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.