Infinix™ Universal Composite is a packable (high viscosity) dental composite filling material, intended for direct anterior and posterior restorations, class V restorations, veneering of discolored anterior teeth, and repair of composite/ceramic veneers. The resin matrix of the Infinix™ Universal Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA). The inorganic filler of the Infinix™ Universal 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 (OASi), added to maintain the integrity of the restoration. The Infinix™ Universal Composite is provided in syringes (4 g) and in single-dose capsules (0.2 g) and is available in five shades (A1, A2, A3, B1 and translucent).

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a dental resin material named "Infinix™ Universal Composite". This submission focuses on demonstrating substantial equivalence to a predicate device based on material properties and non-clinical testing. It does not describe a study involving algorithms, human readers, or image analysis for diagnostic purposes.

Therefore, most of the requested information regarding acceptance criteria, device performance in a diagnostic context, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document as it pertains to a different type of medical device and evaluation.

However, I can extract the non-clinical performance criteria and reported performance from the document.

1. A table of acceptance criteria and the reported device performance

The document lists various non-clinical tests performed on the Infinix™ Universal Composite to establish substantial equivalence to the predicate device, Tetric EvoCeram®, and compliance with ISO 4049 and FDA guidance. The acceptance criteria are implicitly those defined by these standards and guidance documents. The document states that the device "performs as intended based on the bench testing per ISO 4049 and FDA guidance document". Specific numerical results for "reported device performance" are not provided in this summary, but the general conclusion is that the device met these criteria.

Acceptance Criteria (Implied by Standard/Guidance)	Infinix™ Universal Composite Performance (Reported)
Biocompatibility (ISO 10993, ISO 7405)	Biocompatible (based on assessment of Cytotoxicity, Oral Mucosal Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Bacterial Reverse Mutation, Mouse Lymphoma Assay, Biological Risk Assessment)
Flexural Strength (ISO 4049:2009)	Performed as intended (Met ISO 4049:2009 criteria)
Elastic Modulus	Performed as intended
Compression Strength	Performed as intended
Shade and Color Stability	Performed as intended
Polymerization Conversion Degree	Performed as intended
Viscosity	Performed as intended
Spontaneous Polymerization Sensitivity at Ambient Light (ISO 4049:2009)	Performed as intended (Met ISO 4049:2009 criteria)
Water Solubility (ISO 4049:2009)	Performed as intended (Met ISO 4049:2009 criteria)
Water Sorption (ISO 4049:2009)	Performed as intended (Met ISO 4049:2009 criteria)
Depth of Cure (ISO 4049:2009)	Performed as intended (Met ISO 4049:2009 criteria)
Radio-opacity (ISO 4049:2009)	Performed as intended (Met ISO 4049:2009 criteria)
Knoop Hardness	Performed as intended
Preservation of Surface Integrity	Performed as intended
Intensity for curing	$\geq550 \text{ mW/cm}^2$
Wavelength for curing	$430-490 \text{ nm}$
Curing time	$20 \text{ sec.}$

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. The study pertains to non-clinical bench testing and biocompatibility assessments of a dental material, not a diagnostic device with test sets of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. Ground truth in the context of this device would relate to the physicochemical properties and biocompatibility of the material, not expert interpretation of diagnostic data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are relevant for expert review of human data, not for material property testing.

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

No such study was done or is described. This device is a dental filling material, not an AI-powered diagnostic tool.

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

No such study was done or is described. This device is a dental filling material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's evaluation is based on established scientific and regulatory standards for material properties and biocompatibility as outlined in ISO 4049, ISO 10993, ISO 7405, and FDA guidance for dental composite resin devices. It's objective, quantitative measurements against these standards.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" in the context of material property evaluation for a dental composite.

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

This information is not applicable and not provided for the reasons stated above.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 13, 2019

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

Re: K182921

Trade/Device Name: Infinix Universal Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: June 13, 2019 Received: June 18, 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.

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

{1}------------------------------------------------

er Federal agencies. You must comply with all the Act's
registration and listing (21 CFR Part 807); labeling (21 CFR Part

Page 2

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,

Srinivas Nandkumar, Ph.D. Acting 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K182921

Device Name InfinixTM Universal Composite

Indications for Use (Describe)

The InfinixTM Universal Composite is indicated for:

· Restorations in the posterior region (Class I and II)
· Anterior restorations (Class III, IV)
· Class V restorations (cervical caries, root erosion, wedge-shaped defects)
· Veneering of discolored anterior teeth
· Splinting of mobile teeth
· Extended fissure sealing in molars and premolars
· Repair of composite/ceramic veneers

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) SUMMARY [as required by section 807.92(c)] Infinix™ Universal Composite 510(k) Number K183921

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:

June 12, 2019

5.2 DEVICE

Trade Name: Infinix™ Universal Composite

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

5.3 PREDICATE DEVICE

Tetric EvoCeram®, manufactured by Ivoclar Vivadent, cleared under K042819 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:

Infinix™ Flowable Composite cleared under K182580. •
. Clearfil Protect Bond cleared under K033938
. Orthodontic Acrylic cleared under K141439 and Orthodontic Acrylic 2 cleared under K163482.

{4}------------------------------------------------

5.4 DEVICE DESCRIPTION

The inorganic filler of the Infinix™ Universal 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 (OASi), 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 Infinix™ Universal Composite is provided in syringes (4 g) and in single-dose capsules (0.2 g) and is available in five shades (A1, A2, A3, B1 and translucent).

ર્સ્ડ INDICATIONS FOR USE

Infinix™ Universal Composite is indicated for use in:

Restorations in the posterior region (Class I and II) ●
Anterior restorations (Class III, IV) ●
Class V restorations (cervical caries, root erosion, wedge-shaped defects) ●
. Veneering of discolored anterior teeth
. Splinting of mobile teeth
Extended fissure sealing in molars and premolars ●
. Repair of composite/ceramic veneers

5.6 SUBSTANTIAL EQUIVALENCE

The InfinixTM Universal Composite has the same indications as the Tetric EvoCeram® by Ivoclar Vivadent.

The technological characteristics of the Infinix™ Universal Composite are substantially equivalent to these of the predicate device, the Infinix™ Flowable Composite and other methacrylate-based products currently on the market. Table 5-1 below shows a comparison of Infinix™ Universal Composite and the predicate device.

{5}------------------------------------------------

Feature	Infinix™ Universal Composite	Tetric EvoCeram
510(k) Number	K182921	K042819
Classification	EBF	EBF
Indications	• Restorations in the posterior region(Classes I and II)• Anterior restorations (Classes III, IV)• Class V restorations (cervical caries,root erosion, wedge-shaped defects)• Veneering of discolored anterior teeth• Splinting of mobile teeth• Extended fissure sealing in molars andpremolars• Repair of composite/ceramic veneers	• Restoration of deciduous teeth• Restorations in the posterior region(Classes I and II)• Anterior restorations (Classes III, IV)• Class V restorations (cervical caries,root erosion, wedge-shaped defects)• Veneering of discolored anterior teeth• Splinting of mobile teeth• Extended fissure sealing in molars andpremolars• Repair of composite/ceramic veneers• Build-ups for transparent, removable,Invisalign® orthodontic retainers
Composition	Methacrylate resins, photo-initiators, inorganic fillers	Methacrylate resins, photo-initiators, inorganic fillers
Packaging	Syringe and single-dose capsule	Syringe and single-dose capsule
FlexuralStrength	ISO 4049:2009	ISO 4049:2009
Intensity forcuring	≥550 mW/cm2	500 -1000 mW/cm2
Wavelength forcuring	430-490 nm	400-500 nm
Curing time	20 sec.	10 -20 sec* depending on shade
Radio-opacity	ISO 4049: 2009	ISO 4049: 2009
Depth of Cure	ISO 4049: 2009	ISO 4049: 2009
Water Sorption	ISO 4049:2009	ISO 4049:2009
WaterSolubility	ISO 4049:2009	ISO 4049:2009
SpontaneousPolymerizationSensitivity atAmbient Light	ISO 4049:2009	ISO 4049:2009

Table 5-1: Comparison of Infinix™ Universal Composite and Tetric EvoCeram®

{6}------------------------------------------------

5.7 PERFORMANCE DATA

Non-Clinical Performance Testing:

Non-clinical and biological testing was completed to assess the performance and biocompatibility of the Infinix™ Universal 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 Infinix™ Universal 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.

5.8 CONCLUSION

Nobio Ltd. believes that Infinix™ Universal Composite is substantially equivalent to the Tetric EvoCeram®, the Infinix™ Flowable Composite and other legally marketed products. It does not introduce new indications for use, has similar technological characteristics and does not introduce any new safety or effectiveness concerns.

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.