Lucitone Digital Print™ 3D Denture Base is a light-cured resin indicated for the fabrication of denture bases including full and partial dentures and implant overdentures, and implant overdentures and other dental appliances.
Lucitone Digital Value™ 3D Economy Tooth & Trial Placement is used as a try-in material for evaluation prior to fabrication of the final restoration or a temporary denture.
Lucitone Digital IPN™ 3D Premium Tooth is a light-cured resin intended for printing denture teeth.
Lucitone Digital Value™ 3D Economy Tooth & Trial Placement is intended for printing full arch and tooth segments.
Lucitone Digital Fuse™ Step 1 - 3D Tooth Conditioning Agent is indicated for use in enhancing the bond of denture teeth to denture base and denture base to denture base.
Lucitone Digital Fuse™ Step 2 - 3D Denture Bonding Resin is utilized as an aid in bonding denture teeth to denture base as well as repair using traditional techniques.
Lucitone Digital Fuse™ Step 3 – Total 3D Sealer is a light-cured sealant that produces a smooth, glossy surface finish on the denture.

Device Description

Lucitone Digital Print Denture System is a methacrylate-based, light-cured denture base resin which is intended for use by dental clinician to fabricate dental prostheses using an additive printer and CAD/CAM technologies or as a try-in denture. The workflow utilizes several support components that aid in conditioning, bonding or sealing to provide a smooth finish to the device. The Lucitone Digital Print Denture System conforms to the physical and mechanical property requirements for ISO 20795-1:2013.

AI/ML Overview

This looks like a 510(k) summary for a medical device. Based on the provided text, there is no clinical performance data included to describe acceptance criteria or prove the device meets acceptance criteria through a study involving human subjects or AI performance metrics.

The document explicitly states:
"8. Clinical Performance Data
Not applicable, no data from human clinical studies has been included to support the substantial equivalence of the proposed Lucitone Digital Print Denture System."

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the 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
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

The provided document focuses on non-clinical performance data and adherence to ISO standards and FDA guidance documents for medical devices (specifically denture base resins and additive manufacturing), demonstrating substantial equivalence to a predicate device. This typically involves bench testing, material properties, and biocompatibility, not clinical studies or AI performance evaluations as described in your prompt.

Summary

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October 20, 2023

Dentsply Sirona Rebecca Sporer Principle Regulatory Affairs Specialist 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401

Re: K231578

Trade/Device Name: Lucitone Digital Print Denture System Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI, KLE, PZY, EBD Dated: Mav 31, 2023 Received: May 31, 2023

Dear Rebecca Sporer:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -2

Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and ENT Devices

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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

Submission Number (if known)

K231578

Device Name

Lucitone Digital Print Denture System

Indications for Use (Describe)

· Lucitone Digital Print™ 3D Denture Base is a light-cured resin indicated for the fabrication of denture bases including full and partial dentures and implant overdentures, and implant overdentures and other dental appliances.

· Lucitone Digital Value™ 3D Economy Tooth & Trial Placement is used as a try-in material for evaluation prior to fabrication of the final restoration or a temporary denture.

· Lucitone Digital IPN™ 3D Premium Tooth is a light-cured resin intended for printing denture teeth.

· Lucitone Digital Value™ 3D Economy Tooth & Trial Placement is intended for printing full arch and tooth segments.

· Lucitone Digital Fuse™ Step 1 - 3D Tooth Conditioning Agent is indicated for use in enhancing the bond of denture teeth to denture base and denture base to denture base.

· Lucitone Digital Fuse™ Step 2 - 3D Denture Bonding Resin is utilized as an aid in bonding denture teeth to denture base as well as repair using traditional techniques.

· Lucitone Digital Fuse™ Step 3 – Total 3D Sealer is a light-cured sealant that produces a smooth, glossy surface finish on the denture.

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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Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

Image /page/4/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized, abstract shape on the left, resembling a leaf or a curved form with a white line running through it. To the right of the shape are the words "Dentsply" on the top line and "Sirona" on the bottom line, both in a simple, sans-serif font.

510(k) SUMMARY

for

Lucitone Digital Print Denture System (K231578)

1. Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17404
  Contact Person: Ms. Rebecca Sporer Telephone Number: 717-353-1150 Email address: Corporate-RA@dentsplysirona.com

19 October 2023 Date Prepared:

1. Device Name:

Proprietary Name:	Lucitone Digital Print Denture System
Common Name:	Denture relining, repairing or rebasing resin
Classification Name:	Resin, Denture, Relining, Repairing, Rebasing
CFR Number:	21 CFR 872.3760
Device Class:	II
Product Code:	EBI, KLE, EBD, EBG

3. Predicate Device:

Table FS.1: Predicate and Reference device information
Device Type	Predicate Device Name	510(k)	Company Name
Primary Predicate Device	Halley Resin System	K191427	Dentsply Sirona
Predicate Device	Eclipse Bonding Agent	K051707	Dentsply Sirona
Reference Device	Halley Resin	K190043	Dentsply Sirona
Reference Device	TempFX Esthetic Provisional System	K061264	Dentsply Sirona

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4. Description of Device:

5. Indications for Use:

Indications for Use for the proposed device are:

Lucitone Digital Print™ 3D Denture Base is a light-cured resin indicated for the fabrication of ● denture bases including full and partial dentures and implant overdentures, and implant overdentures and other dental appliances.
Lucitone Digital Value™ 3D Economy Tooth & Trial Placement is used as a try-in material for . evaluation prior to fabrication of the final restoration or a temporary denture.
. Lucitone Digital IPN™ 3D Premium Tooth is a light-cured resin intended for printing denture teeth.
. Lucitone Digital Value™ 3D Economy Tooth & Trial Placement is intended for printing full arch and tooth segments.
Lucitone Digital Fuse™ Step 1 3D Tooth Conditioning Agent is indicated for use in enhancing . the bond of denture teeth to denture base and denture base to denture base.
Lucitone Digital Fuse™ Step 2 3D Denture Bonding Resin is utilized as an aid in bonding . denture teeth to denture base as well as repair using traditional techniques.
Lucitone Digital Fuse™ Step 3 Total 3D Sealer is a light-cured sealant that produces a smooth, . glossy surface finish on the denture.

Table FS.2 compares the proposed Indications for Use with those of the predicate and reference devices.

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Table FS.2 - Indications for Use Side-by-Side Comparison
Proposed DeviceLucitone Digital PrintDenture System(K231578)	PrimaryPredicateDeviceHalley ResinSystem(K191427)	ReferenceDeviceHalley Resin(K190043)	PredicateDevice EclipseBonding Agent(K051707)	Reference DeviceTempFXEstheticProvisionalSystem(K061264)	Differences
• Lucitone DigitalPrint 3D DentureBase is a light-curedresin indicated forthe fabrication ofdenture basesincluding full andpartial dentures andimplant overdenturesand other dentalappliances.	Halley resin is a light-cured resinindicated for the fabrication ofdentures bases in dentallaboratories, including full andpartial dentures as well as implantoverdentures, and other dentalappliances.		N/A	N/A	Similar.-The proposed deviceindication does not state "indental laboratories" as theproposed device is targetedfor use by dentalprofessionals in a dentallaboratory or a clinicalsetting.-Product name "LucitoneDigital Print 3D DentureBase" instead of "Halleyresin"
• Lucitone DigitalIPNTM 3D PremiumTooth is a light-curedresin intended forprinting dentureteeth.			N/A	N/A	Different. Additionalcomponent in indication.-The additional indicationfor use falls under the scopeof product code PZY(additively manufactured,preformed, resin denturetooth) which is 510(k)exempt device.
• Lucitone DigitalValue 3D EconomyTooth & TrialPlacement is used asa try-in material forevaluation prior to	Halley resin can be used as a try-inmaterial for evaluation prior tofabrication of the final restoration.		N/A	N/A	Similar.-The proposed Try-indenture can also be used as atemporary denture. Theextension of use is supportedby physical and mechanical
Table FS.2 - Indications for Use Side-by-Side Comparison
Proposed DeviceLucitone Digital PrintDenture System(K231578)	PrimaryPredicateDeviceHalley ResinSystem(K191427)	ReferenceDeviceHalley Resin(K190043)	PredicateDevice EclipseBonding Agent(K051707)	Reference DeviceTempFXEstheticProvisionalSystem(K061264)	Differences
fabrication of thefinal restoration, or atemporary denture					properties per ISO 20795-1:2013 Dentistry – Basepolymers - Part 1: Denturebase polymers;-Product name "LucitoneDigital Value 3D PremiumTooth & Trial Placement"instead of "Halley resin"
• Lucitone DigitalValue™ 3DEconomy Tooth &Trial Placement isintended for printingfull arch and toothsegments.			N/A	N/A	Different. Additionalcomponent in indication.-The additional indicationfor use falls under the scopeof product code PZY(additively manufactured,preformed, resin denturetooth) which is 510(k)exempt device.
• Lucitone DigitalFuse Step 1- 3DTooth ConditioningAgent is indicatedfor use in enhancingthe bond of dentureteeth to denture baseand denture base todenture base.	Halley Denture Tooth BondingAgent is indicated for the use inenhancing the bond of denture baseto denture base.		Eclipse®Bonding Agentis indicated foruse in enhancingthe bond ofacrylic teeth toacrylicremovabledenture base.	N/A	Similar.-Additional indication foruse for bonding dentureteeth to the denture basecleared in the predicatedevice (K051707) (identicalformulation).
Table FS.2 - Indications for Use Side-by-Side Comparison
Proposed DeviceLucitone Digital PrintDenture System(K231578)	PrimaryPredicateDeviceHalley ResinSystem(K191427)	ReferenceDeviceHalley Resin(K190043)	PredicateDevice EclipseBonding Agent(K051707)	Reference DeviceTempFXEstheticProvisionalSystem(K061264)	Differences
					-Product name "LucitoneDigital Fuse Step 1 – 3DTooth Conditioning Agent"instead of "Halley DentureTooth Bonding Agent"
• Lucitone DigitalFuse Step 2- 3DDenture BondingResin in utilized asan aid in bondingdenture teeth todenture base as wellas repair usingtraditionaltechniques.	Halley resin can be utilized as anaid in bonding denture base todenture teeth as well as repair usingtraditional techniques.		N/A	N/A	Similar.-Reworded for clarification.-Product name "LucitoneDigital Fuse Step 2 - 3DDenture Bonding Resin"instead of "Halley resin"
• Lucitone DigitalFuse Step 3 - Total3D Sealer is a light-cured sealant thatproduces a smooth,glossy surface finishon the denture.	Halley Sealer is light-cured sealantthat produces a smooth, glossysurface finish on the denture.		N/A	TEMPFXESTHETICPROVISIONALSYSTEM isindicated forfabrication ofprovisional dentalrestorations.	Same-Product name "LucitoneDigital Fuse Step 3 – Total3D Sealer" instead of"Halley Sealer"

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6. Comparison of Technological Characteristics:

The proposed Lucitone Digital Print Denture System includes the addition of the Primeprint 3D printer workflow. The workflow has been modified to include new packaging (cartridge), the use of a new washing agent, and minor modifications when compared to the primary predicate device workflow (K191427). The overall sequential workflow between the dentist (or dental professional) and the dental laboratory of the proposed Lucitone Digital Print Denture System is identical to the workflow of the primary predicate device Halley Resin System (K1 91427). Although the packaging of the resin was modified, the formulation of the denture base resin and try-in denture resin remain the same as the predicate device (K191427). Both the proposed and predicate device have comparable percent extractables, which confirms the biological safety of the proposed device.

The proposed device was also modified to include cumulative changes made to the predicate device (K191427). There were minor formulation updates to ancillary components of the system in trace percentages. Biological safety testing was performed to confirm the biological safety of the proposed device in comparison with the predicate device.

7. Non-Clinical Performance Data

The proposed device was tested and conforms to ISO 20795-1:2013 Type 4 materials and follows FDA guidance documents:

1. Denture Base Resins - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (April 2022)
1. FDA Guidance Technical Considerations for Additive Manufactured Medical Devices (December 2017). The proposed device meets the same technological requirements as the predicate device (Kl 91427).

8. Clinical Performance Data

Not applicable, no data from human clinical studies has been included to support the substantial equivalence of the proposed Lucitone Digital Print Denture System.

9. Conclusion

Minor differences in the technological characteristics between the proposed and predicate (K191427) device were evaluated through appropriate performance and biocompatibility testing which demonstrates that the proposed device, when compared to the predicate device,

does not raise new questions regarding safety and effectiveness. Therefore, nonclinical testing data supports the conclusion that the proposed device is substantially equivalent to the predicate device (K191427).

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.