NextDent Denture 3D+ is a light-cured resin indicated for the fabrication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The material is an alternative to traditional heat cured and auto polymerization resins. NextDent Denture 3D+ is intended exclusively for professional dental work. Fabrication of denture bases with NextDent Denture 3D+ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following scanner, design software, additive printer and post-cure unit:

Device Description

Light-Cure Resin, provided in a container. NextDent Denture 3D+ dimethacrylic system, polymerized via photo initiators in a 3D printer setting. The color of the denture is determined by the addition of pigments. NextDent™ Denture 3D+ must be used in combination with the NextDent™ 5100 Figure4® 3D printer. Printer and resin must be optimized to each other in order to get complete and precise printed parts. If printer and resin are not optimized to each other this may have an adverse effect on the accuracy and physical quality of printed parts. The NextDent™ 5100 Figure4® 3D printer and the post-curing lightbox NextDent™ LC-PrintBox make use of a light source to polymerize the NextDent resin.

AI/ML Overview

The provided text describes the acceptance criteria and the study results for the NextDent Denture 3D+ device, which is a light-cured resin for fabricating denture bases.

Here's an breakdown of the requested information:

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

The device was tested for conformity with ISO 20795-1:2013 Dentistry – Base polymers - Part 1: Denture base polymers.
The acceptance criteria are the requirements defined in this standard for Type 4 materials.

Acceptance Criteria (from ISO 20795-1:2013 for Type 4 Materials)	Reported Device Performance (NextDent Denture 3D+)
Mechanical properties (e.g., Ultimate Flexural strength, Flexural modulus, Water sorption, Water solubility, Residual monomer)	Compliant to requirements defined in ISO 20795-1 for Type 4 materials.
Biocompatibility (Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity, Subacute/subchronic systemic toxicity, Genotoxicity)	Compliant to requirements defined in ISO 10993-1/C1:2010, including parts 3, 5, 10, and 11, for permanent medical devices.
Re-use of print resin material	Can be used safely without impacting biological safety.
Residual monomers on 3D printed parts before post-curing	No monomers remain on the surface due to cleaning steps.
Printability and accuracy (horizontal and vertical orientation, build location, resin re-use)	Can be repeatedly and successfully printed with 80% accuracy of 100 µm; worst-case average product density of 6.39 g/mm, at 18-28°C.
Shelf-life	2 years.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each test performed (e.g., number of test specimens for flexural strength, number of samples for biocompatibility).

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the submitter is Vertex-Dental B.V. from The Netherlands, suggesting the testing was likely conducted in Europe or by contractors for a European company.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable (N/A) as the device is a material (resin) and not an AI/software device that requires expert judgment for ground truth establishment. The ground truth here refers to the compliance with established physical, chemical, and biological standards.

4. Adjudication method for the test set

This information is N/A for the same reasons as above. The evaluation of material properties against ISO standards does not typically involve human adjudication in the way an AI diagnostic tool would.

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 information is N/A. The device is a material (resin) for 3D printing dentures, not an AI-assisted diagnostic tool.

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

This information is N/A. The device is a material, not an algorithm.

7. The type of ground truth used

The ground truth used for this device is based on established industry standards and regulatory requirements:

Physical and Chemical Properties: ISO 20795-1:2013 Dentistry – Base polymers - Part 1: Denture base polymers.
Biocompatibility: ISO 7405:2008/A1:2013 and ISO 10993-1:2009/C1:2010 (including parts 3, 5, 10, and 11).

8. The sample size for the training set

This information is N/A. The device is a material, not a machine learning model, so there is no "training set" in the context of AI.

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

This information is N/A. As stated above, there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

November 1, 2019

Vertex-Dental BV % Patsy Trisler Consultant Qserve Group US Inc. 5600 Wisconsin Avenue Chevy Chase, Maryland 20815

Re: K191497

Trade/Device Name: NextDent Denture 3D+ Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: September 3, 2019 Received: October 2, 2019

Dear Patsy Trisler:

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 medical devices and radiation-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,

for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental 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

510(k) Number (if known) K191497

Device Name NextDent Denture 3D+

Indications for Use (Describe)

Design:
Scanner	3Shape
Type	D900
Software
Design software	3Shape
Type	Dental-System 2016 Premium
Printing:
Printer	3D Systems
Type	NextDent 5100 Figure4®
Software	3D Sprint
Post-curing:
Post-cure unit	NextDent
Type	LC-3DPrint Box
Software	n.a.

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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K191497

Section 5.0

510(k) SUMMARY-- NextDent Denture 3D+

I. SUBMITTER
Submitter Name:	Vertex-Dental B.V.
Submitter Address:	Centurionbaan 1903769 AV Soesterberg The Netherlands
Contact Person:Telephone #:	L. Vloet-Emonts+31 88 61 60 430
Date Prepared:	September 27, 2019
II. DEVICE
Device Trade Name:	NextDent Denture 3D+
Common andClassification Name(s):	Resin, Denture
Classification #:	21 CFR 872.3760
Product Code	EBI
Regulatory Class	2
III. PREDICATEDEVICE(s)
	NextDent Denture, K162572No reference devices were used in this submission.
IV. DEVICEDESCRIPTION
Device Identification:	Light-Cure Resin, provided in a container.
Device Characteristics:	NextDent Denture 3D+ dimethacrylic system, polymerizedvia photo initiators in a 3D printer setting. The color of thedenture is determined by the addition of pigments.
Environment of Use:	Healthcare facility/hospitalDental (technical) laboratory.
Summary (Description)of Device:	NextDent™ Denture 3D+ must be used in combination withthe NextDent™ 5100 Figure4® 3D printer.Printer and resin must be optimized to each other in order toget complete and precise printed parts. If printer and resinare not optimized to each other this may have an adverseeffect on the accuracy and physical quality of printed parts.The NextDent™ 5100 Figure4® 3D printer and the post-curing lightbox NextDent™ LC-PrintBox make use of a lightsource to polymerize the NextDent resin. Therefore weadvise to wear UV protective glasses when operating a 3Dprinter and/or lightbox. Differences in color nuance mayoccur due to:production in batches;inadequate shaking and mixing of
	the original packaging before use; inadequate stirring in the resin Denture 3D+ before use; insufficient post-curing 3D printer is not included with the device.
Materials of Use:	methacrylate-based resins with photo-initiator, filler and pigments.

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V. INDICATIONS FORUSE	NextDent Denture 3D+ is a light-cured resin indicated forthe fabrication of denture bases fabricated in dentallaboratories, including full and partial removable dentures.The material is an alternative to traditional heat cured andauto polymerization resins. NextDent Denture 3D+ isintended exclusively for professional dental work.Fabrication of denture bases with NextDent Denture 3D+requires a computer-aided and manufacturing (CAD/CAM)system that includes the following scanner, design software,additive printer and post-cure unit:
---------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--	--

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VI. COMPARISON OFTECHNOLOGICALCHARACTERISTICSWITH THEPREDICATE DEVICE	Both NextDent™ Denture 3D+ and the predicate device have the following similar characteristics:Pre-mixed light-cure resins with photo-initiator and pigments Polymerization by visible light Automated printing of resin in multiple layers, each light-cured before adding next layer, with post curing in light chamber Post curing by visible light-curing unit The difference is in the chemical composition of the specific resin.
	Technologicalcharacteristics		Predicate device:NextDent™ Denture		New device:NextDent™ Denture 3D+
		Brand	Type	Software	Brand	Type	Software
	Design:Scanner	3Shape	D900	Dental-System2016-Premium	3Shape	D900	Dental-System2016-Premium
	Printing:	EnvisionTec	DDDP4	Perfectory
		RapidShape	D30	Netfabb		NextDent5100Figure 4®	3D Sprint
	Printer	Miicraft	125Y /	MiiUtilityMiicontroller	3DSystems
		3DSystems	Figure4®	3D Sprint
		Roland DG	DWP-80S	Ver1.1
	Post-Curing:
	Post-cureunit	NextDent™	LC-3DPrintbox	n.a.	NextDent™	LC-3DPrintBox	n.a.
VII. SUMMARY OFTESTING[PERFORMANCEDATA]	NextDent™ Denture 3D+ has been tested for mechanical properties as part of the product specification. The most applicable standard for mechanical characteristics determination of denture base polymers and copolymers is the ISO 20975-1: 2013 Dentistry - Base polymers - Part 1:Denture base polymers.
BiocompatibilityTesting:	According to ISO 7405:2008/A1:2013 NextDent™ Denture 3D+ is considered a surface device, in contact with the mucosal membrane, for > 30 days.The ISO 10993-1:2009/C1:2010 standard, including parts 3, 5, 10 and 11, was followed and the following biological safety aspects have been addressed:Cytotoxicity Sensitization Irritation or intracutaneous reactivity Subacute/subchronic systemic toxicity Genotoxicity

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	In addition, the following risks have been considered basedon a risk assessment, taking into account the specific natureand duration of exposure to the device Carcinogenicity Reproductive/developmental/organ toxicity Immunotoxicity Furthermore, it is demonstrated that Re-use of print resin material (stored under thecorrect conditions) without the introduction ofrecycling steps can be used safely without impactingthe biological safety No monomers remain on the surface of the 3Dprinted parts before post-curing due to cleaningsteps according to IFU
	NextDent Denture 3D+ is compliant to the requirementsdefined in ISO 10993-1/C1:2010, including parts 3, 5, 10and 11, for permanent medical devices.
Bench Testing	NextDent Denture 3D+ has been tested for conformity withthe industry standard ISO 20795-1:2013 Dentistry – Basepolymers - Part 1: Denture base polymers.
	NextDent Denture 3D+ is compliant to the requirementsdefined in ISO 20975-1 for Type 4 materials.
	The following bench tests are conducted on NextDentDenture 3D+: Ultimate Flexural strength Flexural modulus Water sorption Water solubility Residual monomer Biocompatibility
	NextDent Denture 3D+ can be repeatedly and successfullyprinted on all NextDent 5100 Figure4® printers andcomplies to all requirements defined in ISO 20975-1 forType 4 materials. The medical device may be printed withhorizontal and vertical orientation independent of the buildlocation in the build space, with the possibility to re-useresin, within 80% accuracy of 100 µm, with an worst-caseaverage product density of 6.39 g/mm, at a temperaturerange of 18°C to 28°C.
Reprocessing, Sterilityand Shelf-Life Testing	The device is provided non-sterile.From the Shelf life testing, NextDent Denture 3D+ has ashelf life of 2 years.
VIII. CONCLUSIONS	NextDent Denture 3D+ and the predicate have the sameintended use and similar technological characteristics.

	The results of the performed tests show that NextDentDenture 3D+ meets the requirements mentioned in theapplicable standards, and confirm that the device performssimilarly to the predicate device.
	It is therefore concluded that NextDent Denture 3D+ is safeand performs as intended, and is substantially equivalent tothe predicate device.

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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.