Who is the manufacturer of NextDent Base?

Vertex-Dental B.V. filed the 510(k) submission for NextDent Base (K231388).

What is the FDA product code for NextDent Base?

EBI. It is classified under 21 CFR 872.3760 as a Class 2 device in the Dental panel.

What is the regulatory pathway for NextDent Base?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like NextDent Base?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NextDent Base

Q: What are the predicate devices for NextDent Base?

NextDent Denture 3D+ (K191497).

K231388 · Vertex-Dental B.V. · EBI · Oct 20, 2023 · Dental

Device Facts

Record ID	K231388
Device Name	NextDent Base
Applicant	Vertex-Dental B.V.
Product Code	EBI · Dental
Decision Date	Oct 20, 2023
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 872.3760
Device Class	Class 2

Intended Use

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 Story

NextDent Base is an acrylate-based light-cure resin used for 3D printing denture bases. The device is intended for use in dental laboratories by dental professionals. The process involves using a VAT-based 3D printer (e.g., NextDent 5100 Figure 4) and 3D Sprint software to print the resin in layers, with each layer cured by UV light. Post-printing, parts are cured in a UV light chamber (e.g., NextDent LC-3DPrint Box) and finished using conventional dental methods. The device enables the fabrication of custom denture bases, supporting artificial teeth for removable dentures. The resin's mechanical properties and biocompatibility are verified to ensure safety and performance for permanent oral contact.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility per ISO 10993-1:2018 (cytotoxicity, sensitization, irritation, genotoxicity, systemic toxicity) and ISO 7405:2018. Mechanical performance was verified against ISO 20795-1:2013, including flexural strength, modulus, impact strength, sorption, solubility, and color stability. Results confirmed compliance with requirements for denture base polymers and substantial equivalence to the predicate.

Technological Characteristics

Pre-mixed acrylate-based UV light-cure resin containing pigments and photo-initiators. Polymerization via UV light source in a 3D printer and post-curing chamber. Compliant with ISO 20795-1:2013 and ISO 10993-1:2018. Non-sterile. Shelf life of two years.

Indications for Use

Indicated for dental professionals to manufacture denture bases supporting artificial teeth for full or partial removable dentures.

Regulatory Classification

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.

Predicate Devices

NextDent Denture 3D+ (K191497)

Related Devices

K191497 — NextDent Denture 3D+ · Vertex-Dental B.V. · Nov 1, 2019
K162572 — NextDent Denture, E-Denture · Vertex-Dental B.V. · Jun 30, 2017
K220042 — Dentca Base Premium, Dentca Base Hi-Impact · Dentca, Inc. · Nov 17, 2022
K243356 — Asiga DentaBASE · Asiga Pty, Ltd. · Apr 11, 2025
K242884 — Additively Manufactured Denture Resin · Aidite (Qinhuangdao) Technology Co., Ltd. · Nov 22, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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" {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 -5 For Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and {2}------------------------------------------------ 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 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ### K231388 Section 5.0 ## 510(k) SUMMARY— NextDent Base | I. SUBMITTER | | |--------------------|----------------------------------------------------------| | Submitter Name: | Vertex-Dental B.V. | | Submitter Address: | Centurionbaan 190 3769 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 | | Classification Regulation | 21 CFR 872.3760 | | III. PREDICATE | NextDent Denture 3D+, K191497 (Primary Predicate) | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | DEVICE(s) | | | | | | IV. DEVICE DESCRIPTION | | | Device Identification: | Light-Cure Resin, provided in a container. | | Device Characteristics: | 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. | | Environment of Use: | Healthcare facility/hospital Dental (technical) laboratory. | | Summary (Description) of Device: | 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. | {5}------------------------------------------------ | | Printing Printer | Brand | Type | Software | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------------------------|-----------| | | | 3D Systems | NextDent 5100 Figure 4 | 3D Sprint | | | Post-Curing Post-cure unit | Brand | Type | Software | | | | NextDent | LC-3DPrint Box | n.a. | | Fit of the parts strongly depends on design and library used. Features like undercuts and spacers should be taken in consideration when designing the parts. | | | | | | Both the NextDentTM 5100 Figure4® 3D printer and the post-curing lightbox NextDentTM LC-3DPrint Box make use of 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 methods and instruments. NextDent 3D printed cured parts should be cleaned with nonchemical products. | | | | | | Materials of Use: | A combination of acrylate-based resins with photo-initiator and pigments. | | | | | V. INTENDED USE / INDICATIONS FOR USE | 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. | | | | | VI. TECHNOLOGICAL CHARACTERISTICS | NextDent Base is a pre-mixed acrylate-based UV light-cure resin with pigments and polymerized via photo initiators in a 3D printer setting. Automated printing of the resin in multiple layers, each light-cured before adding next layer, are post- cured in the UV light chamber. The cured parts are finished using dental methods. | | | | | VII. COMPARISON TO THE PREDICATE DEVICE: | Both NextDent Base and the predicate device are resins intended for the manufacturing of 3D printed full and partial removable denture bases. | | | | | INTENDED USE: | Both devices are intended exclusively for professional dental work. | | | | | TECHNOLOGICAL CHARACTERISTICS: | Both NextDent Base and the predicate device have the following similar characteristics: | | | | {6}------------------------------------------------ | | • Pre-mixed light-cure combination of acrylate-based resin with photo-initiator • Polymerization and post-curing by UV light • Automated printing of resin with the same 3D printer and software in multiple layers, each light-cured before adding next layer, with post curing in lightchamber • Finished by using dental methods | | | | | | | |------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|----------------------------------|------------------------------|---------------|-------------------------------|-----------| | | Technological characteristics | Predicate device | | New device: NextDent Base | | | | | | | Brand | Type | Software | Brand | Type | Software | | | Design: Printer | 3D Systems | NextDent 5100 Figure 4® | 3D Sprint | 3D Systems | NextDent 5100 Figure 4® | 3D Sprint | | | Post-Curing: | | | | | | | | | Post-cure unit | NextDentTM | LC- 3DPrint Box | n.a. | NextDentTM | LC- 3DPrint Box | n.a. | | VIII. SUMMARY OF TESTING [PERFORMANCE DATA] | NextDent Base is tested for mechanical characteristics as part of the product specification. The most applicable standard for mechanical characteristics determination of denture bases is ISO 20795-1:2013 Dentistry - Base polymers - Part 1 Denture base polymers. | | | | | | | | Biocompatibility Testing: | According to both ISO 7405:2018 and ISO 10993-1: 2018 NextDent Base is considered a surface device, in contact with intact oral mucosa, permanent (> 30 days), repeated use. The ISO 10993-1:2018 standard, including parts 3, 5, 10, 12, 17, 18 and 23 was followed and the following applicable biological safety hazard endpoints were addressed: • Chemical characterization • Cytotoxicity • Acute systemic toxicity • Subacute/sub chronic toxicity • Irritation or intracutaneous reactivity • Sensitization • Genotoxicity In addition, the following risks were considered based on a risk assessment, taking into account the specific nature and duration of exposure to the device • Material mediated pyrogenicity • Chronic toxicity • Presence of phthalates In addition, ISO 10993-17 and -18 and ISO/TS 21726 were followed to identify and quantitate the extractables and/or leachables that may be released from the test article to | | | | | | | {7}------------------------------------------------ | | NextDent Base is compliant to the applicable requirements defined in ISO 10993 including parts 1, 3, 5, 10, 12, 17, 18 and 23, ISO 7405 and ISO/TS 21726 for permanent medical devices and therefore biocompatible. | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Bench Testing | NextDent Base is tested according to the methods in the industry standard ISO 20795-1:2013 Dentistry – Base polymers - Part 1 Denture base polymers. | | | NextDent Base is compliant to the requirements defined in ISO 20795-2:2013 for Type 4 light activated material except for ultimate flexural strength, flexural modulus and water solubility. Comparative testing showed that elasticity and impact resistance properties are substantially equivalent to the predicate. NextDent Base is regarding water solubility compliant to requirements defined in ISO 20795-1:2013 for type 2 autopolymerizable materials. The following bench tests 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 on the NextDent 5100 printer is verified confirming its sufficient repeatability and robustness regarding print orientation, placement, and resin reuse. | | Reprocessing, Sterility and Shelf-Life Testing | The device is provided non-sterile. From the Shelf-life testing, NextDent Base has a shelf life of two years. | | IX. CONCLUSIONS | NextDent Base and the predicate have the same intended use and similar technological characteristics. | |-----------------|---------------------------------------------------------------------------------------------------------------------| | | The results of the performed tests show that NextDent Base meets the applicable requirements of ISO 20795-1:2013 | {8}------------------------------------------------ | Dentistry - Base polymers – Part 1 Denture base polymers and confirm that the device performs similarly to the predicate device. | |----------------------------------------------------------------------------------------------------------------------------------------| | It is therefore concluded that NextDent Base performs as intended and is substantially equivalent to the predicate device. |