(54 days)
Not Found
No
The summary describes a resin system for 3D printing dental prostheses using CAD/CAM technologies. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is a resin system used for fabricating dental prostheses like denture bases and teeth, which are replacements for missing teeth, rather than a device that treats a condition or disease.
No
Explanation: The device is a resin system used for fabricating dental prostheses (denture bases, denture teeth, provisional crowns, bridges). Its intended use and device description focus on the manufacturing and material properties of these dental products, not on diagnosing medical conditions.
No
The device description clearly states it is a "methacrylate-based resin system" used to fabricate dental prostheses, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a light-cured resin for fabricating dental prostheses (denture bases, teeth, provisional crowns/bridges). This is a manufacturing process for a medical device that is placed in the body, not a test performed on a biological sample to diagnose a condition.
- Device Description: The description confirms it's a methacrylate-based resin system used with additive printing for fabricating dental prostheses.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, providing diagnostic information, or any other typical characteristics of an IVD.
The device falls under the category of a dental prosthetic material used in the fabrication of medical devices (dentures, crowns, bridges).
N/A
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
EBI, KLE, PZY, EBD, EBG
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.
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
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength: ≥50 MPa.
Water Sorption:
§ 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.
0
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.
1
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
2
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
3
Indications for Use
Submission Number (if known)
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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4
Dentsply Sirona Inc 221 West Philadelphia Street Suite 60W York, PA 17401
K243336
510(k) SUMMARY
-
- 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
- Submitter Information: Dentsply Sirona Inc 221 West Philadelphia Street Suite 60W York, PA 17401
Date Prepared: October 22, 2024
-
- 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 |
5
4. Description of Device:
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.
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: Lucitone | ||
| Digital Print™ Denture | |||
| System | 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 | |
| Performance | |||
| Testing | |||
| Flexural | |||
| Strength | |||
| (MPa) | ≥50 MPa. | ≥50 MPa. | |
| Flexural | |||
| Modulus | |||
| (MPa) | Acceptable | Acceptable | |
| Water | |||
| Sorption | |||
| (µg/mm³) |