NextDent Base is for dental professional use only and intended for the manufacturing of denture bases to support artificial teeth to form full or partial removable dentures.

Device Description

Light-Cure Resin, provided in a container. NextDent Base is a combination of acrylate-based light-cure resin with pigments, polymerized via photo initiators in a 3D printer setting for fabrication of denture bases to support artificial teeth to form full or partial removable dentures. Fabrication of denture bases with NextDent Base requires a VAT based 3D printer that supports NextDent resins. Printer and resin must be optimized to each other to get complete and precise printed parts.

AI/ML Overview

The provided document is a 510(k) summary for a dental device called "NextDent Base." It describes the device, its intended use, and a summary of testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria for a specific AI-powered medical device, nor does it present a study proving an AI device meets such criteria.

The document is solely about a dental material (resin for denture bases) and its mechanical and biological safety testing against established ISO standards for dental polymers. There is no mention of AI, machine learning, or software performance in the context of device acceptance or a study.

Therefore, I cannot fulfill your request for an AI device's acceptance criteria and a study proving it meets them based on the provided text. The questions you've asked are designed for AI/software as a medical device (SaMD) submissions, which this document is not.

Summary

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October 20, 2023

Vertex-Dental B.V. % Patsy Trisler, Jd, Rac Consultant Oserve Group US Inc. 350 S. Main Street Doylestown, Pennsylvania 18901

Re: K231388

Trade/Device Name: NextDent Base Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: October 2, 2023 Received: October 2, 2023

Dear Patsy Trisler, Jd, Rac:

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 -5

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

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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

510(k) Number (if known)

K231388

Device Name NextDent Base

Indications for Use (Describe)

NextDent Base is for dental professional use only and intended for the manufacturing of denture bases to support artificial teeth to form full or partial removable dentures.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K231388 Section 5.0

510(k) SUMMARY— NextDent Base

I. SUBMITTER
Submitter Name:	Vertex-Dental B.V.
Submitter Address:	Centurionbaan 1903769 AV Soesterberg The Netherlands
Contact Person:	N.C. - Peterse – van der Koppel
Telephone #:	+31 88 61 60 430
Date Prepared:	October 20, 2023

II. DEVICE
Device Trade Name:	NextDent Base
Common Name(s):	Resin, denture
Classification Name	Resin, denture, relining, repairing, rebasing
Product Codes	EBI
Regulatory Class	Class 2
ClassificationRegulation	21 CFR 872.3760

III. PREDICATE	NextDent Denture 3D+, K191497 (Primary Predicate)
DEVICE(s)

IV. DEVICEDESCRIPTION
Device Identification:	Light-Cure Resin, provided in a container.
Device Characteristics:	NextDent Base is a combination of acrylate-based light-cureresin with pigments, polymerized via photo initiators in a 3Dprinter setting for fabrication of denture bases to supportartificial teeth to form full or partial removable dentures.
Environment of Use:	Healthcare facility/hospital Dental (technical) laboratory.
Summary (Description)of Device:	Fabrication of denture bases with NextDent Base requires aVAT based 3D printer that supports NextDent resins.Printer and resin must be optimized to each other to getcomplete and precise printed parts.

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	PrintingPrinter	Brand	Type	Software
		3D Systems	NextDent5100 Figure4	3D Sprint
	Post-CuringPost-cureunit	Brand	Type	Software
		NextDent	LC-3DPrintBox	n.a.
Fit of the parts strongly depends on design and library used.Features like undercuts and spacers should be taken inconsideration when designing the parts.
Both the NextDentTM 5100 Figure4® 3D printer and thepost-curing lightbox NextDentTM LC-3DPrint Box make useof a UV light source to polymerize the NextDent Base resin.
NextDentTM5100 Figure4® 3D printer or NextDentTM LC-3DPrint Box is not included with the device.
Cured parts are finished using conventional dental methodsand instruments. NextDent 3D printed cured parts should becleaned with nonchemical products.
Materials of Use:	A combination of acrylate-based resins with photo-initiatorand pigments.
V. INTENDED USE /INDICATIONS FORUSE	NextDent Base is for dental professional use only andintended for the manufacturing of denture bases tosupport artificial teeth to form full or partial removabledentures.
VI. TECHNOLOGICALCHARACTERISTICS	NextDent Base is a pre-mixed acrylate-based UV light-cureresin with pigments and polymerized via photo initiators in a 3Dprinter setting. Automated printing of the resin in multiplelayers, each light-cured before adding next layer, are post-cured in the UV light chamber. The cured parts are finishedusing dental methods.
VII. COMPARISONTO THE PREDICATEDEVICE:	Both NextDent Base and the predicate device are resinsintended for the manufacturing of 3D printed full and partialremovable denture bases.
INTENDED USE:	Both devices are intended exclusively for professionaldental work.
TECHNOLOGICALCHARACTERISTICS:	Both NextDent Base and the predicate device have thefollowing similar characteristics:

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	• Pre-mixed light-cure combination of acrylate-basedresin with photo-initiator• Polymerization and post-curing by UV light• Automated printing of resin with the same 3D printerand software in multiple layers, each light-curedbefore adding next layer, with post curing in lightchamber• Finished by using dental methods
	Technologicalcharacteristics	Predicate device		New device:NextDent Base
		Brand	Type	Software	Brand	Type	Software
	Design:Printer	3DSystems	NextDent5100Figure4®	3D Sprint	3DSystems	NextDent5100Figure 4®	3D Sprint
	Post-Curing:
	Post-cureunit	NextDentTM	LC-3DPrintBox	n.a.	NextDentTM	LC-3DPrintBox	n.a.
VIII. SUMMARY OFTESTING[PERFORMANCEDATA]	NextDent Base is tested for mechanical characteristics aspart of the product specification. The most applicablestandard for mechanical characteristics determination ofdenture bases is ISO 20795-1:2013 Dentistry - Basepolymers - Part 1 Denture base polymers.
BiocompatibilityTesting:	According to both ISO 7405:2018 and ISO 10993-1: 2018NextDent Base is considered a surface device, in contactwith intact oral mucosa, permanent (> 30 days), repeateduse.The ISO 10993-1:2018 standard, including parts 3, 5, 10,12, 17, 18 and 23 was followed and the following applicablebiological safety hazard endpoints were addressed:• Chemical characterization• Cytotoxicity• Acute systemic toxicity• Subacute/sub chronic toxicity• Irritation or intracutaneous reactivity• Sensitization• GenotoxicityIn addition, the following risks were considered based on arisk assessment, taking into account the specific nature andduration of exposure to the device• Material mediated pyrogenicity• Chronic toxicity• Presence of phthalatesIn addition, ISO 10993-17 and -18 and ISO/TS 21726 werefollowed to identify and quantitate the extractables and/orleachables that may be released from the test article to

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	NextDent Base is compliant to the applicable requirementsdefined in ISO 10993 including parts 1, 3, 5, 10, 12, 17, 18and 23, ISO 7405 and ISO/TS 21726 for permanent medicaldevices and therefore biocompatible.
Bench Testing	NextDent Base is tested according to the methods in theindustry standard ISO 20795-1:2013 Dentistry – Basepolymers - Part 1 Denture base polymers.
	NextDent Base is compliant to the requirements defined inISO 20795-2:2013 for Type 4 light activated material exceptfor ultimate flexural strength, flexural modulus and watersolubility. Comparative testing showed that elasticity andimpact resistance properties are substantially equivalent tothe predicate. NextDent Base is regarding water solubilitycompliant to requirements defined in ISO 20795-1:2013 fortype 2 autopolymerizable materials. The following benchtests are conducted on NextDent Base:Surface characteristics Polishability Color Color stability Translucency Freedom from porosity Ultimate flexural strength Flexural modulus Charpy impact strength Bonding to synthetic polymer teeth Sorption Solubility Dynamic fatigue Fracture work
	The mechanical performance of NextDent Base printed onthe NextDent 5100 printer is verified confirming its sufficientrepeatability and robustness regarding print orientation,placement, and resin reuse.
Reprocessing, Sterilityand Shelf-Life Testing	The device is provided non-sterile.From the Shelf-life testing, NextDent Base has a shelf life oftwo years.

IX. CONCLUSIONS	NextDent Base and the predicate have the same intendeduse and similar technological characteristics.
	The results of the performed tests show that NextDent Basemeets the applicable requirements of ISO 20795-1:2013

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Dentistry - Base polymers – Part 1 Denture base polymersand confirm that the device performs similarly to thepredicate device.
It is therefore concluded that NextDent Base performs asintended and is substantially equivalent to the predicatedevice.

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.