SprintRay OnX Tough is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture.

Device Description

OnX Tough resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need.

Fabrication of dental prosthetics with OnX Tough resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital denture file created in an optical impression system, 3D printer, and curing light equipment.

The material is an alternative to traditional dental prostheses material. OnX Tough resin is intended exclusively for professional dental work.

OnX Tough resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SprintRay OnX Tough device.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not typically on a standalone clinical study demonstrating the device's diagnostic performance against a "ground truth" established by experts, as would be common for AI/ML devices. Therefore, many of the requested points from your prompt (like sample size for test sets, expert qualifications, MRMC studies, standalone algorithm performance, training set details) are not applicable in this context as this is a dental material, not an AI/ML diagnostic device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device, OnX Tough, was tested against industry consensus standards, primarily ISO 20795-1 and ISO 20795-2, which set the acceptance criteria for denture base polymers. Biocompatibility testing was also conducted according to ISO 10993-1, among others.

Performance Metric	Acceptance Criteria (Standard Reference)	Reported OnX Tough Performance
Biocompatibility	ISO 10993-1, -3, -5, -10, -11	Passed
Flexural Strength	≥65 MPa (ISO 20795-1)	71.03 ± 1.45 MPa
Flexural Modulus	≥2000 MPa (ISO 20795-1)	2271 ± 118 MPa
Sorption	≤32 µg/mm³ (ISO 20795-2)	31 ± 1 µg/mm³
Solubility	≤5 µg/mm³ (ISO 20795-2)	4.0 ± 0.5 µg/mm³
Residual Methyl Methacrylate Monomers	≤2.2% (ISO 20795-1)	Pass
Kmax	≥1.9 MPa*m^(1/2) (ISO 20795-1)	3.176 ± 0.209
Total Fracture Work	≥900 J/m² (ISO 20795-1)	945 ± 88 J/m²
Other Bench Tests	ISO 20795-1 (various)	Functioned as intended

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

The document does not specify the exact sample sizes (e.g., number of test specimens for each mechanical test) used for the bench testing. This information is typically detailed in the full test reports, not usually in the 510(k) summary. Given this is a material properties verification, the "data provenance" is typically laboratory testing results, not patient data from a specific country or collected retrospectively/prospectively.

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

Not Applicable. This is a material science and biocompatibility assessment, not a diagnostic device relying on expert interpretation of results to establish ground truth for a clinical condition. The "ground truth" for these tests is the quantitative measurement against established physical/chemical standards.

4. Adjudication Method for the Test Set

Not Applicable. As above, this is laboratory bench testing against objective criteria, not a clinical study requiring adjudication of expert interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. This is a dental material, not an AI-assisted diagnostic tool. Therefore, MRMC studies evaluating human reader improvement with or without AI assistance are irrelevant to this device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not Applicable. This is a physical dental material, not an algorithm or software. Its performance is evaluated through material property testing and biocompatibility.

7. Type of Ground Truth Used

The "ground truth" used for this device is based on established international standards for physical, mechanical, and chemical properties of dental materials (ISO 20795 series) and biocompatibility standards (ISO 10993 series). These are objective, quantitative benchmarks, not subjective expert consensus, pathology, or outcomes data in the sense of a diagnostic medical device.

8. Sample Size for the Training Set

Not Applicable. This is a manufactured dental resin, not a machine learning model that requires a training set. The development of the resin would involve material science research and iterative formulation, not data training in the context of AI.

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

Not Applicable. As explained above, there is no "training set" in the context of an AI/ML algorithm for this device. The material's formulation and properties are developed through chemical engineering and material science principles, with validation against performance specifications derived from ISO standards.

Summary

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July 14, 2023

SprintRay Inc. Sara Moghtadernejad Regulatory Affairs 2705 Media Center Drive, Suite 100A Los Angeles, California 90065

Re: K230445

Trade/Device Name: OnX Tough Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI, PZY Dated: May 18, 2023 Received: May 19, 2023

Dear Sara Moghtadernejad:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and ENT 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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510(k) Number (if known)

K230445

Device Name

OnX Tough

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY OnX Tough K230445

Submitter: SprintRay Inc. 2705 Media Center Drive, Suite 100A Los Angeles. CA 90065

Phone: (800) 914-8004

Contact Person: Sara Moghtadernejad

Date Prepared: July 12, 2023

Name of Device:	OnX Tough
Common or Usual Name	Denture, Prescription
Regulation Number andNames:	21 CFR 872.3760,Denture Relining,Repairing, or RebasingResin	21 CFR 872.3590,Additively Manufactured,Preformed, ResinDenture Tooth
Product Codes	EBI	PZY
Device Class	II	II510(k)-Exempt
Primary Predicate	K221678, SprintRay High Impact Denture Base,(EBI product code)
Secondary Predicate	K151142, IvoBase CAD for Zenotec,(EBI product code)

Device Description

The material is an alternative to traditional dental prostheses material. OnX Tough resin is intended exclusively for professional dental work.

OnX Tough resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile,

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and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.

Intended Use / Indications for Use

The intended use of fabrication of monolithic full and partial removable dentures is the same as the primary predicate device (K221678) (product code EBI). The fabrication of hybrid denture prosthetics, implant-supported denture prosthetics is the same as the secondary predicate device (K151142) (product code EBI). The fabrication of preformed denture teeth to be used in a denture is Class II, but 510(k)-exempt (product code PZY), therefore no predicate is necessary.

The intended use, technological characteristics, and critical specifications, of OnX Tough are similar to both predicate devices.

Summary of Technological Characteristics

OnX Tough and the primary predicate device (K221678) are both 3D printed denture devices. The liquid resin is polymerized in the 3D printer. which creates the final denture device. The secondary predicate device (K151142) is a prepolymerized denture disk that is milled to the final shape of the impression. Here is a more detailed explanation of the two processes:

OnX Tough and Primary Predicate Device

1. An impression of the patient's mouth is taken.
1. The impression is scanned and sent to a 3D printer.
1. The 3D printer creates a mold of the denture.
1. The mold is filled with liquid resin.
1. The resin is polymerized, which creates the final denture device.

Secondary Predicate Device

1. An impression of the patient's mouth is taken.
1. The impression is scanned and sent to a computer.
1. A pre-polymerized denture disk is created on the computer.
1. The disk is milled to the final shape of the impression.
1. The milled disk is placed in the patient's mouth.

Both OnX Tough and the primary predicate device are created using 3D printing technology. This technology allows for the creation of custom-fit dentures that are more comfortable and durable than traditional dentures. The secondary predicate device is a less expensive option that is still effective in providing patients with a new set of teeth. The principles of operation are essentially similar; therefore, the OnX Tough is substantially equivalent to its predicate devices.

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The following technological differences exist between the subject and predicate devices:

Differences in acrylate resin material. ●

Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for OnX Tough was conducted in accordance with the FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1 and ISO 7405, as recognized by FDA. The battery of testing included the following tests:

Genotoxicity ●
Cytotoxicity ●
. Acute Systematic Toxicity
Sensitization ●
. Irritation

OnX Tough is considered tissue contacting for a period longer than 30 days (a removable prosthesis).

Bench Testing

OnX Tough was tested for conformity with the industry consensus standard ISO 20795-1. The battery of testing included the following tests:

Flexural Strength and Modulus ●
Water Sorption and Solubility .
. Stability
Residual Methyl Methacrylate Monomers ●
Homogeneity ●
Surface Characteristics ●
Shape Capability, Translucency, and Polishability
Freedom from Porosity
Color Stability ●

Additive Manufacturing

Testing, according to FDA's guidance Technical Considerations for Additive Manufactured Medical Devices, was performed and results were provided in the 510(k). These tests included evaluation of all relevant properties of the printed resin using the permitted machines. Further, tests based on considerations of the orientation during manufacturing were also performed.

In all instances, OnX Tough functioned as intended and the outcomes were as expected.

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EQUIVALENCE TO MARKETED DEVICES

	TestingStandards	High ImpactDenture Base(PrimaryPredicate)	IvoBase CADfor Zenotec(SecondaryPredicate)	OnX Tough(Subject Device)
Intended Use &Indications forUse	N/A	The SprintRayHigh ImpactDenture Baseresin is a lightcurablepolymerizableresin intendedto be used forthe fabricationand repair, offull and partialremovabledentures andbaseplates. Thematerial is analternative totraditionaldenture basematerial.	IvoBase CADfor Zenotec,IvoBase CADBond andModellingLiquid is asystem used:For thefabrication ofremovabledentures e.g.:partial andcompletedentureprosthetics,hybrid dentureprosthetics,combineddentureprosthetics,mouthguards,implant-supporteddentureprosthetics	SprintRay OnXTough is a toothshade ceramic-hybrid resin usedfor the fabricationof hybrid dentureprosthetics,implant-supporteddenture prosthetics,monolithic full andpartial removabledentures, andpreformed dentureteeth to be used ina denture.
User Population	N/A	Clinicians indental offices	Clinicians indental offices	Clinicians in dentaloffices
Biocompatibility	ISO- 10993-1,-3, -5, -10and -11	Passed	Passed	Passed
Composition	N/A	MethacrylateMonomer/oligomer s thatpolymerized toMethymethacylate Basedpolymer	TraditionalPMMAPolymer/monomer denturebase materialwithpigmentationfor shade.	MethacrylateMonomer/oligomersthat polymerized toMethymethacylateBased polymer. Thesubject device hassimilar polymerfamily to thepredicates exceptfor small changes inpigments.
Principles ofoperation	N/A	Additivemanufacturingof thepolymerizeddenture to thefinalshape of theimpression.	Polymerizeddenture diskmilled to thefinal shape oftheimpression.	Additivemanufacturing ofthe polymerizeddenture to the finalshape of theimpression.
PerformanceTesting		Testingperformedaccording toISO standards	Testingperformedaccording toISO standards	Testing performedaccording to ISOstandards
Flexural Strength(≥65 MPa)	ISO 20795-1	$74.69 ± 1.55$ MPa	≥65 MPa	$71.03 ± 1.45$ MPa
Flexural Modulus(≥2000 MPa)	ISO 20795-1	$2253 ± 78$ MPa	≥2000 MPa	$2271 ± 118$ MPa
Sorption (≤32 µg/mm³)	ISO 20795-2	$28 ± 1$ µg/mm³	≤32 µg/mm³	$31 ± 1$ µg/mm³
Solubility (≤5 µg/mm³)	ISO 20795-2	$3.5 ± 0.5$ µg/mm³	≤5 µg/mm³	$4.0 ± 0.5$ µg/mm³
Monomer MethylMethacrylate(≤2.2%)	ISO 20795-1	Pass	Pass	Pass
Kmax ≥1.9MPa*m1/2	ISO 20795-1	$3.328 ± 0.147$	2.5	$3.176 ± 0.209$
Total fracturework,≥900 J/m²	ISO 20795-1	$1232 ± 119$	1172	$945 ± 88$

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Conclusions

The OnX Tough resin is as safe and effective as its predicate devices. The OnX Tough has the same intended use and indication, and similar technological characteristics as its predicate devices. The minor technological differences between the OnX Tough and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the OnX Tough is as safe and effective as the predicate devices. Thus, the OnX Tough is substantially equivalent.

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.

1. Table of Acceptance Criteria and Reported Device Performance

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

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

4. Adjudication Method for the Test Set

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

7. Type of Ground Truth Used

8. Sample Size for the Training Set

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

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

510(k) SUMMARY OnX Tough K230445

Device Description

Intended Use / Indications for Use

Summary of Technological Characteristics

OnX Tough and Primary Predicate Device

Secondary Predicate Device

Performance Data

Biocompatibility Testing

Bench Testing

Additive Manufacturing

EQUIVALENCE TO MARKETED DEVICES

Conclusions

§ 872.3760 Denture relining, repairing, or rebasing resin.

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