Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system of light-cured resins and associated components for fabricating dentures using additive printing and CAD/CAM technologies. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the material properties and manufacturing process.

Therapeutic

Yes
The device is used to fabricate dental prostheses (denture bases, full and partial dentures, implant overdentures, temporary dentures) for use by dental clinicians on patients.

Diagnostic

No
The text describes the device as a light-cured resin used for fabricating dental prostheses (dentures, overdentures). The intended use and device description clearly indicate it is a material used in the creation of a medical device, not a device used to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "methacrylate-based, light-cured denture base resin" and mentions "additive printer and CAD/CAM technologies," indicating it is a physical material and manufacturing process, not solely software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended uses described are for the fabrication of dental prostheses (dentures, partial dentures, implant overdentures, etc.), try-in materials, and bonding/sealing agents for these prostheses. These are all applications related to the physical structure and function of the mouth and teeth.
Device Description: The device is described as a light-cured resin system used with additive printing and CAD/CAM technologies to fabricate dental prostheses.
Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. IVDs are used to perform tests on samples (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.

The device is clearly intended for the fabrication and finishing of dental prostheses, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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, 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.

Product codes (comma separated list FDA assigned to the subject device)

EBI, KLE, PZY, EBD

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental clinician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Denture Base Resins - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (April 2022)
FDA Guidance Technical Considerations for Additive Manufactured Medical Devices (December 2017).
The proposed device meets the same technological requirements as the predicate device (K191427).
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).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K191427, K051707

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K190043, K061264

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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"

1

(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

2

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

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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:

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.

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 Device
Lucitone Digital Print
Denture System
(K231578)	Primary
Predicate
Device
Halley Resin
System
(K191427)	Reference
Device
Halley Resin
(K190043)	Predicate
Device Eclipse
Bonding Agent
(K051707)	Reference Device
TempFX
Esthetic
Provisional
System
(K061264)	Differences
• 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 other dental
appliances.	Halley resin is a light-cured resin
indicated for the fabrication of
dentures bases in dental
laboratories, including full and
partial dentures as well as implant
overdentures, and other dental
appliances.		N/A	N/A	Similar.
-The proposed device
indication does not state "in
dental laboratories" as the
proposed device is targeted
for use by dental
professionals in a dental
laboratory or a clinical
setting.
-Product name "Lucitone
Digital Print 3D Denture
Base" instead of "Halley
resin"
• Lucitone Digital
IPNTM 3D Premium
Tooth is a light-cured
resin intended for
printing denture
teeth.			N/A	N/A	Different. Additional
component in indication.
-The additional indication
for use falls under the scope
of product code PZY
(additively manufactured,
preformed, resin denture
tooth) which is 510(k)
exempt device.
• Lucitone Digital
Value 3D Economy
Tooth & Trial
Placement is used as
a try-in material for
evaluation prior to	Halley resin can be used as a try-in
material for evaluation prior to
fabrication of the final restoration.		N/A	N/A	Similar.
-The proposed Try-in
denture can also be used as a
temporary denture. The
extension of use is supported
by physical and mechanical
Table FS.2 - Indications for Use Side-by-Side Comparison
Proposed Device
Lucitone Digital Print
Denture System
(K231578)	Primary
Predicate
Device
Halley Resin
System
(K191427)	Reference
Device
Halley Resin
(K190043)	Predicate
Device Eclipse
Bonding Agent
(K051707)	Reference Device
TempFX
Esthetic
Provisional
System
(K061264)	Differences
fabrication of the
final restoration, or a
temporary denture					properties per ISO 20795-
1:2013 Dentistry – Base
polymers - Part 1: Denture
base polymers;

-Product name "Lucitone
Digital Value 3D Premium
Tooth & Trial Placement"
instead of "Halley resin" |
| • Lucitone Digital
Value™ 3D
Economy Tooth &
Trial Placement is
intended for printing
full arch and tooth
segments. | | | N/A | N/A | Different. Additional
component in indication.
-The additional indication
for use falls under the scope
of product code PZY
(additively manufactured,
preformed, resin denture
tooth) which is 510(k)
exempt device. |
| • 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. | Halley Denture Tooth Bonding
Agent is indicated for the use in
enhancing the bond of denture base
to denture base. | | Eclipse®
Bonding Agent
is indicated for
use in enhancing
the bond of
acrylic teeth to
acrylic
removable
denture base. | N/A | Similar.
-Additional indication for
use for bonding denture
teeth to the denture base
cleared in the predicate
device (K051707) (identical
formulation). |
| Table FS.2 - Indications for Use Side-by-Side Comparison | | | | | |
| Proposed Device
Lucitone Digital Print
Denture System
(K231578) | Primary
Predicate
Device
Halley Resin
System
(K191427) | Reference
Device
Halley Resin
(K190043) | Predicate
Device Eclipse
Bonding Agent
(K051707) | Reference Device
TempFX
Esthetic
Provisional
System
(K061264) | Differences |
| | | | | | -Product name "Lucitone
Digital Fuse Step 1 – 3D
Tooth Conditioning Agent"
instead of "Halley Denture
Tooth Bonding Agent" |
| • Lucitone Digital
Fuse Step 2- 3D
Denture Bonding
Resin in utilized as
an aid in bonding
denture teeth to
denture base as well
as repair using
traditional
techniques. | Halley resin can be utilized as an
aid in bonding denture base to
denture teeth as well as repair using
traditional techniques. | | N/A | N/A | Similar.
-Reworded for clarification.
-Product name "Lucitone
Digital Fuse Step 2 - 3D
Denture Bonding Resin"
instead of "Halley resin" |
| • Lucitone Digital
Fuse Step 3 - Total
3D Sealer is a light-
cured sealant that
produces a smooth,
glossy surface finish
on the denture. | Halley Sealer is light-cured sealant
that produces a smooth, glossy
surface finish on the denture. | | N/A | TEMPFX
ESTHETIC
PROVISIONAL
SYSTEM is
indicated for
fabrication of
provisional dental
restorations. | Same
-Product name "Lucitone
Digital Fuse Step 3 – Total
3D Sealer" instead of
"Halley Sealer" |

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8

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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).