SprintRay Digital Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.

Device Description

SprintRay Digital Crown 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 SprintRay Digital Crown resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital crown file created in an optical impression system, 3D printer, and curing light equipment. SprintRay Digital Crown Resin is intended exclusively for professional dental work. Digital Crown Resin is offered in following shades/colors: Bleach, A1, B1.

The device is manufactured via additive manufacturing process using a 3D printer with 405 nm wavelength, 50 m print layer thickness, and light energy of 28.8 mW/cm².

Digital Crown resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered nonsterile, 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 provided document is a 510(k) Summary for the SprintRay Digital Crown resin. It describes the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information concerning acceptance criteria and study details:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance values. Instead, it states that "In all instances, Digital Crown resin functioned as intended and the outcomes were as expected" for the various bench tests. It also indicates that the device met ISO standards.

However, the "Comparison of Technology Characteristics" table implicitly conveys acceptance criteria by listing the standards that both the predicate and the subject device adhere to, and then stating "Similar" for the reported performance.

Here's a reconstructed table based on the provided information, focusing on the standards and the conclusion of compliance:

Feature/Test	Acceptance Criteria (Implied by Standard Adherence)	Reported Device Performance
Biocompatibility	ISO 10993-1, ISO 7405	Tested and considered compliant.
Genotoxicity	ISO 10993-3	Tested, outcomes as expected.
Cytotoxicity	ISO 10993-5	Tested, outcomes as expected.
Acute Systemic Toxicity	ISO 10993-11	Tested, outcomes as expected.
Sensitization	ISO 10993-10	Tested, outcomes as expected.
Irritation	ISO 10993-10	Tested, outcomes as expected.
Bench Testing	ISO 10477, ISO 4049	Functioned as intended, outcomes as expected.
Flexural Strength and Modulus	ISO 10477, ISO 4049	Functioned as intended, outcomes as expected.
Water Sorption and Solubility	ISO 10477, ISO 4049	Functioned as intended, outcomes as expected.
Radio-opacity	ISO 10477, ISO 4049 (Likely subsumed)	Functioned as intended, outcomes as expected.
Print Accuracy and Dimensional Stability	ISO 10477, ISO 4049 (Likely subsumed)	Functioned as intended, outcomes as expected.
Shape Capability, Translucency, Polishability	ISO 10477, ISO 4049 (Likely subsumed)	Functioned as intended, outcomes as expected.
Freedom from Porosity	ISO 10477, ISO 4049	Functioned as intended, outcomes as expected.
Color Stability and Shade Consistency	ISO 10477, ISO 4049	Functioned as intended, outcomes as expected.
Residual Methyl Methacrylate Monomers	ISO 10477, ISO 4049	Functioned as intended, outcomes as expected.
Stability	ISO 10477, ISO 4049	Functioned as intended, outcomes as expected.
Additive Manufacturing Properties	FDA Guidance: Technical Considerations for AM Medical Devices	Performed, results provided in 510(k).
Shelf life	>1.5 years (from Predicate)	1.5 years

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

The document does not explicitly state the sample size used for the test set or the data provenance for any of the performance studies (biocompatibility or bench testing). It only refers to "a battery of testing" and "additional bench testing."

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 therefore not provided in the document. The device is a material (resin) for fabricating dental prosthetics, and its performance is evaluated through objective physical, chemical, and biological tests, not through expert assessment of diagnostic accuracy or interpretation of images. Therefore, there's no "ground truth" to be established by experts in the context of diagnostic performance.

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

This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies involving interpretation of medical data (e.g., radiology reads) where discrepancies between assessors need to be resolved to establish ground truth. As this document describes the bench testing of a material, clinical adjudication is irrelevant.

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

This type of study is not applicable to this device. An MRMC study is relevant for AI-powered diagnostic devices that influence human interpretation. The SprintRay Digital Crown is a material for manufacturing dental prosthetics, not an AI diagnostic tool.

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

This information is not applicable. The device is a material, not an algorithm. The performance tests described (biocompatibility and bench testing) evaluate the intrinsic properties of the material and the fabricated dental appliance, not an algorithm's performance.

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

For the biocompatibility and bench testing, the "ground truth" is established by adherence to internationally recognized standards (ISO standards) and scientific test methodologies. For example, flexural strength is measured according to specific protocols outlined in ISO 10477 and ISO 4049, and the result is compared against the requirements specified in those standards. The outcomes of these tests inherently serve as their own "ground truth" concerning the material's properties according to those standards.

8. The sample size for the training set

This information is not applicable as the device is a material and not a machine learning model. There is no concept of a "training set" for the material itself.

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

This information is not applicable (see point 8).

Summary

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December 14, 2022

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

Re: K222623

Trade/Device Name: Digital Crown Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBI, ELM Dated: September 15, 2022 Received: September 15, 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

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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 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,

Image /page/1/Picture/5 description: The image shows the name "Michael E. Adjodha" in a clear, sans-serif font. Below the name, there is a "-S". The background of the image has a faint watermark of the letters "FDA".

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) K222623 Device Name

Digital Crown

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 Digital Crown

K222623

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

Phone: +1 (800) 914-8004

Contact Person: Sara Moghtadernejad

Date Prepared: November 22, 2022

Name of Device:	Digital Crown (K222623)
Common or Usual Name:	Tooth Shade Resin Material
Classification Name:	Tooth Shade Resin Material
Regulatory Class:	Class II
Regulation Number:	21 CFR 872.3690
Product Code:	EBF
Secondary Product Codes:	EBI, ELM
Predicate Device:	E-Dent 1000 (K210977) (Primary Predicate)

Device Description

The device is manufactured via additive manufacturing process using a 3D printer with 405 nm wavelength, 50 m print layer thickness, and light energy of 28.8 mW/cm².

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Intended Use / Indications for Use

Summary of Technological Characteristics

Light-based curing of a 3D printed acrylate resin is the technological principle for both the subject and predicate devices. Digital Crown 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 composition

Performance Data

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

Biocompatibility Testing

The biocompatibility evaluation for Digital Crown 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 ●

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· Irritation
Digital Crown is considered tissue contacting for a period longer than 30 days.

Bench Testing

Additional bench testing based on the test steps laid out in ISO 10477 and ISO 4049 was performed using dental appliance fabricated from Digital Crown resin.

Flexural Strength and Modulus ●
Water Sorption and Solubility
Radio-opacity ●
. Print Accuracy and Dimensional Stability
Shape Capability, Translucency, and Polishability
Freedom from Porosity ●
Color Stability and Shade Consistency ●
Residual Methyl Methacrylate Monomers ●
Stability

In all instances, Digital Crown resin functioned as intended and the outcomes were as expected.

Feature	EnvisionTEC's E-Dent 1000	SprintRay Digital Crown	Conclusion
Product Code	EBFEBIELM	EBFEBIELM	Similar
Regulation	21 CFR 872.369021 CFR 872.376021 CFR 872.3590	21 CFR 872.369021 CFR 872.376021 CFR 872.3590	Similar
Intended Use &Indications for Use	E-Dent 1000 is a light-curable resin indicated for the fabrication of: individual and fixed permanent full single crowns, permanent partial crowns in front and posterior area, individual and fixed single veneers, artificial teeth for dental prostheses, which are used for removable permanent full dentures, individual and removable monolithic full and partial dentures in dental laboratories. The material is an alternative to traditional restorative dental material.E-Dent 1000 is intended	SprintRay Digital Crown is a light-curable polymerizable resin intended to be used for the fabrication of: individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an	Similar
	exclusively for professional dental work. Fabrication of dental applications with E-Dent 1000 requires a computer aided and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression, or in case of artificial teeth for dental prostheses the digital dental files based on manufacturer's data, a digital light processing (DLP) printer, and curing light equipment.	alternative to traditional restorative dental material.
User Population	Clinicians in dental offices	Clinicians in dental offices	Similar
Chemical Description	Methacrylate-based resin	Methacrylate-based resin	Similar
Material Type	Light-curable Resin	Light-curable Resin	Similar
Curing Method	UV Light	UV Light	Similar
Product State	Liquid	Liquid	Similar
Manufacturing Technology Type	Additive	Additive	Similar
Volume provided	1kg bottle	1kg bottle	Similar
Shelf life	>1.5 years	1.5 years	Similar
Standards	ISO 10477ISO 4049	ISO 10477ISO 4049	Similar
Physical and Mechanical Properties	TranslucencyDimensional stabilityColor and color stabilityFlexural Strength and ModulusFreedom from PorosityWater Sorption and SolubilityStability	Shape Capability, Translucency, and Polishability, Radio-opacityPrint Accuracy and Dimensional StabilityColor Stability and Shade ConsistencyFlexural Strength and ModulusFreedom from PorosityWater Sorption and SolubilityStability	Similar
		Residual MethylMethacrylate Monomers
Biocompatibility	Tested to ISO 7405, ISO-10993-1	Tested to ISO 7405, ISO-10993-1	Similar
	Cytotoxicity (Part 5)	Cytotoxicity (Part 5)
	Acute Systematic Toxicity(Part 11)	Acute Systematic Toxicity(Part 11)
	Sensitization (Part 10)	Sensitization (Part 10)
	Irritation (Part 10)	Irritation (Part 10)
		Genotoxicity (Part 3)
AdditiveManufacturing	Testing, according toFDA's guidance TechnicalConsiderations forAdditive ManufacturedMedical Devices, wasperformed and resultswere provided in the510(k). These testsincluded evaluation of allrelevant properties of theprinted resin using thepermitted machines.Further, tests based onconsiderations of theorientation duringmanufacturing wereperformed.	Testing, according toFDA's guidanceTechnicalConsiderations forAdditive ManufacturedMedical Devices, wasperformed and resultswere provided in the510(k). These testsincluded evaluation ofall relevant propertiesof the printed resinusing the permittedmachines. Further,tests based onconsiderations of theorientation duringmanufacturing wereperformed.	Similar
Sterility	Non-sterile	Non-sterile	Similar

Equivalence to Marketed Devices

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Conclusions

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

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.

Digital Crown

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510(k) SUMMARY Digital Crown

Device Description

Intended Use / Indications for Use

Summary of Technological Characteristics

Performance Data

Biocompatibility Testing

Bench Testing

Equivalence to Marketed Devices

Conclusions

§ 872.3690 Tooth shade resin material.

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