· 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.
· 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 use as:
· Printing resin for fabricating removable dentures for try-in and evaluation prior to fabrication of the final denture.*
· Printing resin for fabricating a temporary denture.
· Printing resin for fabricating denture teeth in full arches and segments that will subsequently be fused into a denture base.
· Printing resin for fabricating provisional crowns, bridges.**
• 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.
*Partial and full dentures are replacement for patients with missing teeth.†
**For instructions on printing provisional crowns and bridges with Lucitone Digital Value reference Section G in IFU
+Statement added for EU MDR alignment.

Device Description

Lucitone Digital Value™ (LDV) 3D Economy Tooth & Trial Placement, which is part of the Lucitone Digital Print™ Denture (LDPD) System, is a methacrylate-based resin system which is used to fabricate dental prostheses using an additive printer and computer aided design and computer aided manufacturing (CAD/CAM) technologies.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) summary for a dental device (Lucitone Digital Print Denture™ System) that describes the device, its indications for use, and a few performance tests.

Specifically, the following information is not present in the text:

A comprehensive table of acceptance criteria and reported device performance. While some performance metrics are listed (Flexural Strength, Flexural Modulus, Water Sorption, Water Solubility), these are general and not presented as specific acceptance criteria with corresponding performance test results. For example, for "Flexural Strength," it only states "≥50 MPa" as the acceptance criterion, but it does not report the actual performance value obtained for the subject device.
Sample size used for the test set and data provenance. The document only mentions "In all instances, the subject device functioned as intended and all test results observed were as expected," without providing details about the test set.
Number of experts used to establish ground truth and their qualifications.
Adjudication method.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human improvement with AI assistance. This device is a denture system, not an AI or diagnostic tool, so an MRMC study is highly unlikely to be relevant.
If a standalone (algorithm only without human-in-the-loop performance) study was done. This is not applicable to a physical dental device.
The type of ground truth used. This is not applicable in the context of a physical materials performance study.
Sample size for the training set. This is not applicable as it's not an AI model.
How the ground truth for the training set was established. This is not applicable as it's not an AI model.

The document mainly focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (material properties) and biocompatibility, rather than a clinical study evaluating diagnostic or treatment efficacy that would typically involve test sets, ground truth, and expert adjudication. The "Performance Data" section explicitly states, "Clinical and Pre-clinical testing were not necessary to demonstrate equivalence."

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 17, 2024

Dentsply Sirona Inc. Melanie Avila Regulatory Affairs Director 221 West Philadelphia St. Suite 60W York, Pennsylvania 17401

Re: K243336

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, EBG Dated: October 24, 2024 Received: October 24, 2024

Dear Melanie Avila:

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.

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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" (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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

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assistance/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,

MICHAEL E. ADJODHA -S

Michael E. Adjodha, MChE, RAC, 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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Indications for Use

Submission Number (if known)

K243336

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.

· 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 use as:

· Printing resin for fabricating removable dentures for try-in and evaluation prior to fabrication of the final denture.*

· Printing resin for fabricating a temporary denture.

· Printing resin for fabricating denture teeth in full arches and segments that will subsequently be fused into a denture base.

· Printing resin for fabricating provisional crowns, bridges.**

• 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.

*Partial and full dentures are replacement for patients with missing teeth.†

**For instructions on printing provisional crowns and bridges with Lucitone Digital Value reference Section G in IFU

+Statement added for EU MDR alignment.

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 Inc 221 West Philadelphia Street Suite 60W York, PA 17401

K243336

510(k) SUMMARY

1. Submitter Information: Dentsply Sirona Inc 221 West Philadelphia Street Suite 60W York, PA 17401
  Contact Person: Melanie Avila Telephone Number: 210-262-7724 Email address: melanie.avila@dentsplysirona.com

Date Prepared: October 22, 2024

1. Device Name: Device Trade Name Lucitone Digital Print™ Denture System Common Name: Denture Relining, Repairing, Or Rebasing Resin Temporary Crown and Bridge Classification Name: Resin, Denture, Relining, Repairing, Rebasing Temporary Crown and Bridge Regulation Number 872.3760 872.3770 Device Class: ll Product Code: EBI, KLE, PZY, EBD, EBG

3. Predicate Device:

Primary Predicate Device	510(k)	Company Name
Lucitone Digital Print™ Denture System	K231578	Dentsply Sirona Inc

Secondary Predicate Device	510(k)	Company Name
Dentca Crown and Bridge	K192806	Dentca Inc

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4. Description of Device:

5. Indications for Use:

· 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.

· 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 use as:

· Printing resin for fabricating removable dentures for try-in and evaluation prior to fabrication of the final denture.*
· Printing resin for fabricating a temporary denture.
· Printing resin for fabricating denture teeth in full arches and segments that will subsequently be fused into a denture base.
· Printing resin for fabricating provisional crowns, bridges.**
· 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.

*Partial and full dentures are replacement for patients with missing teeth.†

**For instructions on printing provisional crowns and bridges with Lucitone Digital Value reference Section G in IFU +Statement added for EU MDR alignment.

Summary of the technological characteristics of the device compared to the predicate device[21 CFR 807.92(a)(6)]
Attribute	Subject Device:Lucitone Digital Print™Denture System	Predicate Device: LucitoneDigital Print™ DentureSystem	Predicate Device:Dentca Crown and Bridge
Material	Methacrylate-based resin	Methacrylate-based resin

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Sterility	Non-Sterile	Non-Sterile
Shelf Life	3 years	3 years
PerformanceTesting
FlexuralStrength(MPa)	≥50 MPa.		≥50 MPa.
FlexuralModulus(MPa)	Acceptable		Acceptable
WaterSorption(µg/mm³)	<40 µg/mm³		<40 µg/mm³
WaterSolubility(µg/mm³)	< 7.5 µg /mm³		< 7.5 µg /mm³
Biocompatibility	Meets ISO 10993requirements	Meets ISO 10993requirements

Performance Data

Summary of non-clinical tests conducted for determination of substantial equivalence:

The subject device, LDV, which is part of the LDPD system (primary predicate, cleared under 510(k) K231578) is a resin-based system which is used to fabricate dental prostheses using an additive printer.

Flexural Strength
Flexural Modulus
Water Sorption
. Water Solubility

In all instances, the subject device functioned as intended and all test results observed were as expected.

The testing generated strong evidence that the Lucitone Digital Print™ Denture System has been found to be safe and effective.

Clinical and Pre-clinical testing were not necessary to demonstrate equivalence.

Conclusions

The minor differences in indications for use do not raise any new questions of safety and the performance data established by the predicate, including biocompatibility, shelf-life testing demonstrate substantial equivalence to the predicate.

The subject device's fundamental technology and principles of operation are unchanged compared to the primary predicate device. The subject device's Intended Use remains the same as the predicate device as cleared under K231578.

The subject device is as safe and effective as the predicate devices.

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.