SprintRay Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair, of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.

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

Device Description

SprintRay Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need.

SprintRay Denture Base resin is intended exclusively for professional dental work. SprintRay Denture Base resin is offered in following shades/colors:

Light Pink
Original Pink
Light Meharry
Original Meharry
Extra Light Pink
Medium Pink
Dark Pink
Dark Meharry
Deep Dark Meharry

SprintRay Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility 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

The SprintRay Denture Base is a light-curable polymerizable resin used for the fabrication and repair of full and partial removable dentures and baseplates. The 510(k) summary provides details on the performance data, primarily bench testing, to demonstrate substantial equivalence to the predicate device, Dentca Denture Base (K143033).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for SprintRay Denture Base are based on conformity with the industry consensus standard ISO 20795-1 for dental base polymers, as well as biocompatibility standards. The reported performance indicates that the device met these criteria.

Acceptance Criteria Category	Specific Test Standard / Parameter	Acceptance Criteria (Implicit from ISO 20795-1 and ISO 10993-1)	Reported Device Performance
Biocompatibility	Genotoxicity	Conforming to ISO 10993-1 and ISO 7405 requirements	SprintRay Denture Base considered tissue contacting for >30 days, passed all tests; functioned as intended, outcomes as expected.
	Cytotoxicity	Conforming to ISO 10993-1 and ISO 7405 requirements	Functioned as intended, outcomes as expected.
	Acute Systematic Toxicity	Conforming to ISO 10993-1 and ISO 7405 requirements	Functioned as intended, outcomes as expected.
	Sensitization	Conforming to ISO 10993-1 and ISO 7405 requirements	Functioned as intended, outcomes as expected.
	Irritation	Conforming to ISO 10993-1 and ISO 7405 requirements	Functioned as intended, outcomes as expected.
Bench Testing	Flexural Strength and Modulus	Conforming to ISO 20795-1	Functioned as intended, outcomes as expected.
	Water Sorption and Solubility	Conforming to ISO 20795-1	Functioned as intended, outcomes as expected.
	Stability	Conforming to ISO 20795-1	Functioned as intended, outcomes as expected.
	Residual Methyl Methacrylate Monomers	Conforming to ISO 20795-1	Functioned as intended, outcomes as expected.
	Homogeneity	Conforming to ISO 20795-1	Functioned as intended, outcomes as expected.
	Surface Characteristics	Conforming to ISO 20795-1	Functioned as intended, outcomes as expected.
	Shape Capability, Translucency, and Polishability	Conforming to ISO 20795-1	Functioned as intended, outcomes as expected.
	Freedom from Porosity	Conforming to ISO 20795-1	Functioned as intended, outcomes as expected.
	Color Stability	Conforming to ISO 20795-1	Functioned as intended, outcomes as expected.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes used for the biocompatibility or bench testing. It refers to "battery of testing" for both categories. The provenance of the data is implicit as part of a regulatory submission to the FDA, suggesting the tests were conducted by or for SprintRay Inc. The document does not specify the country of origin of the data or whether it was retrospective or prospective, but for bench and biocompatibility testing of a material, these distinctions are generally less relevant than for clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For bench chemistry and physical property testing, "ground truth" is typically established by certified laboratory equipment and validated test methods, not human expert consensus, so this question is not directly applicable in the usual sense for this type of device.

4. Adjudication method for the test set

Not applicable, as the performance testing described is primarily objective laboratory testing against established standards, not interpretation by human experts.

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. The SprintRay Denture Base is a dental material, not an AI-powered diagnostic or assistive device for human readers. No MRMC study or AI assistance is mentioned or relevant to this device's performance testing.

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

Not applicable. This device is a material, not an algorithm.

7. The type of ground truth used

For biocompatibility testing, the ground truth is established by the accepted biological responses and safety profiles defined in international standards (ISO 10993-1 and ISO 7405) for medical devices.

For bench testing, the ground truth is established by the specified material properties and performance requirements outlined in the industry consensus standard ISO 20795-1 for dental base polymers. The results of physical and chemical tests are compared against the limits and ranges defined by this standard.

8. The sample size for the training set

Not applicable. This device is a material, not a machine learning model, and therefore does not have a "training set" in the context of AI or similar algorithms.

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

Not applicable, as there is no training set for this device.

Summary

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September 14, 2022

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

Re: K220979

Trade/Device Name: SprintRay Denture Base Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: August 16, 2022 Received: August 16, 2022

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 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,

For Michael E. Adjodha, M.ChE. 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)

K220979

Device Name

SprintRay Denture Base

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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-K220979

SprintRay Denture Base

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

Phone:

Contact Person: Sara Moghtadernejad

Date Prepared: March 31, 2022

Name of Device: SprintRay Denture Base

Common or Usual Name: Denture Base, Prescription

Classification Name: Denture Base, Prescription

Regulatory Class: Class II

Regulation Number: 21 CFR 872.3760

Product Code: EBI

Predicate Devices

Dentca Denture Base (K143033)

Device Description

SprintRay Denture Base resin is intended exclusively for professional dental work. SprintRay Denture Base resin is offered in following shades/colors:

Light Pink ●
Original Pink ●
Light Meharry ●
Original Meharry ●
Extra Light Pink ●
Medium Pink ●
Dark Pink ●

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Dark Meharry ●
. Deep Dark Meharry

Intended Use / Indications for Use

Summary of Technological Characteristics

Light-Denture Based curing of a 3D printed acrylate resin is the technological principle for both the subject and predicate devices. SprintRay Denture Base resin is poured into a 3D printer, which relies on scanned images of the patient's oral cavity to produce a dental appliance. At a high level, the subject and predicate devices are based on the following same technological elements:

Are a pourable acrylate resin
· Are used in conjunction with 3D printers, which rely on common 3D images to define the fabricated dental appliance
· Are cured prior to final trimming and cleaning
· Are used for the fabrication of orthodontic and dental appliances

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

· Differences in acrylate resin material

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Performance Data

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

Biocompatibility Testing

The biocompatibility evaluation for SprintRay Denture Base 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 ●

SprintRay Denture Base is considered tissue contacting for a period longer than 30 days (a removable prosthesis).

Bench Testing

SprintRav Denture Base 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 ●

In all instances, SprintRay Denture Base functioned as intended and the outcomes were as expected.

Conclusions

SprintRay Denture Base resin is as safe and effective as its predicate device. SprintRay Denture Base has the same intended use and indication, and similar technological characteristics, and principles of operation as its predicate device. The minor technological differences between SprintRay Denture Base and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that SprintRay Denture Base is as safe and effective as the predicate device. Thus, SprintRay Denture Base 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 the data provenance

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

4. Adjudication method for the test set

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

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

7. The type of ground truth used

8. The sample size for the training set

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

510(k) SUMMARY-K220979

SprintRay Denture Base

Predicate Devices

Device Description

Intended Use / Indications for Use

Summary of Technological Characteristics

Performance Data

Biocompatibility Testing

Bench Testing

Conclusions

§ 872.3760 Denture relining, repairing, or rebasing resin.

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