NextDent Denture 3D+

K191497 · Vertex-Dental B.V. · EBI · Nov 1, 2019 · Dental

Device Facts

• Record ID: K191497
• Device Name: NextDent Denture 3D+
• Applicant: Vertex-Dental B.V.
• Product Code: EBI · Dental
• Decision Date: Nov 1, 2019
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

NextDent Denture 3D+ is a light-cured, methacrylate-based resin used for 3D printing denture bases. The system requires a CAD/CAM workflow: 3Shape scanner/design software, NextDent 5100 Figure 4 3D printer, and NextDent LC-3DPrint Box for post-curing. The resin is polymerized via photo-initiators using light exposure. Used in dental laboratories by technicians; output is a custom-fabricated denture base. The device benefits patients by providing an alternative to traditional heat-cured or auto-polymerizing resins for removable prosthetics. Proper mixing and post-curing are critical for material quality and biocompatibility.

Clinical Evidence

Bench testing only. Compliance with ISO 20795-1:2013 (denture base polymers) and ISO 10993-1:2009/C1:2010 (biocompatibility) demonstrated. Testing included flexural strength, flexural modulus, water sorption, water solubility, residual monomer, and comprehensive biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity).

Technological Characteristics

Methacrylate-based resin with photo-initiators, fillers, and pigments. Polymerization via visible light in 3D printer and post-cure light chamber. Compliant with ISO 20795-1 (Type 4 materials) and ISO 10993. Non-sterile; 2-year shelf life. Requires specific CAD/CAM ecosystem (3Shape scanner/software, NextDent 5100 printer, LC-3DPrint Box).

Indications for Use

Indicated for fabrication of full and partial removable denture bases in dental laboratories by professional dental personnel.

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 (K162572)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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:

| 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 190<br>3769 AV Soesterberg The Netherlands |
| Contact Person:<br>Telephone #: | L. Vloet-Emonts<br>[phone] |
| Date Prepared: | September 27, 2019 |
| II. DEVICE | |
| Device Trade Name: | NextDent Denture 3D+ |
| Common and<br>Classification Name(s): | Resin, Denture |
| Classification #: | 21 CFR 872.3760 |
| Product Code | EBI |
| Regulatory Class | 2 |
| III. PREDICATE<br>DEVICE(s) | |
| | NextDent Denture, K162572<br>No reference devices were used in this submission. |
| IV. DEVICE<br>DESCRIPTION | |
| Device Identification: | Light-Cure Resin, provided in a container. |
| Device Characteristics: | NextDent Denture 3D+ dimethacrylic system, polymerized<br>via photo initiators in a 3D printer setting. The color of the<br>denture is determined by the addition of pigments. |
| Environment of Use: | Healthcare facility/hospital<br>Dental (technical) laboratory. |
| Summary (Description)<br>of Device: | NextDent™ Denture 3D+ must be used in combination with<br>the NextDent™ 5100 Figure4® 3D printer.<br><br>Printer and resin must be optimized to each other in order to<br>get complete and precise printed parts. If printer and resin<br>are not optimized to each other this may have an adverse<br>effect on the accuracy and physical quality of printed parts.<br><br>The NextDent™ 5100 Figure4® 3D printer and the post-<br>curing lightbox NextDent™ LC-PrintBox make use of a light<br>source to polymerize the NextDent resin. Therefore we<br>advise to wear UV protective glasses when operating a 3D<br>printer and/or lightbox. Differences in color nuance may<br>occur due to:<br>production in batches;<br>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 FOR<br>USE | NextDent Denture 3D+ is a light-cured resin indicated for<br>the fabrication of denture bases fabricated in dental<br>laboratories, including full and partial removable dentures.<br>The material is an alternative to traditional heat cured and<br>auto polymerization resins. NextDent Denture 3D+ is<br>intended exclusively for professional dental work.<br>Fabrication of denture bases with NextDent Denture 3D+<br>requires a computer-aided and manufacturing (CAD/CAM)<br>system that includes the following scanner, design software,<br>additive printer and post-cure unit: | | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|

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| VI. COMPARISON OF<br>TECHNOLOGICAL<br>CHARACTERISTICS<br>WITH THE<br>PREDICATE DEVICE | Both NextDent™ Denture 3D+ and the predicate device have the following similar characteristics:<br>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. | | | | | | |
|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------------------------|---------------------------------------|--------------------------------------|-------------------------------|---------------------------------------|
| | Technological<br>characteristics | | Predicate device:<br>NextDent™ Denture | | New device:<br>NextDent™ Denture 3D+ | | |
| | | Brand | Type | Software | Brand | Type | Software |
| | Design:<br>Scanner | 3Shape | D900 | Dental-<br>System<br>2016-<br>Premium | 3Shape | D900 | Dental-<br>System<br>2016-<br>Premium |
| | Printing: | Envision<br>Tec | DDDP<br>4 | Perfectory | | | |
| | | Rapid<br>Shape | D30 | Netfabb | | NextDent<br>5100<br>Figure 4® | 3D Sprint |
| | Printer | Miicraft | 125Y / | MiiUtility<br>Miicontroller | 3D<br>Systems | | |
| | | 3D<br>Systems | Figure<br>4® | 3D Sprint | | | |
| | | Roland DG | DWP-<br>80S | Ver1.1 | | | |
| | Post-Curing: | | | | | | |
| | Post-cure<br>unit | NextDent™ | LC-<br>3DPrint<br>box | n.a. | NextDent™ | LC-<br>3DPrint<br>Box | n.a. |
| VII. SUMMARY OF<br>TESTING<br>[PERFORMANCE<br>DATA] | 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:<br>Denture base polymers. | | | | | | |
| Biocompatibility<br>Testing: | According to ISO 7405:2008/A1:2013 NextDent™ Denture 3D+ is considered a surface device, in contact with the mucosal membrane, for > 30 days.<br>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:<br>Cytotoxicity Sensitization Irritation or intracutaneous reactivity Subacute/subchronic systemic toxicity Genotoxicity | | | | | | |

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| | In addition, the following risks have been considered based<br>on a risk assessment, taking into account the specific nature<br>and 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 the<br>correct conditions) without the introduction of<br>recycling steps can be used safely without impacting<br>the biological safety No monomers remain on the surface of the 3D<br>printed parts before post-curing due to cleaning<br>steps according to IFU |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NextDent Denture 3D+ is compliant to the requirements<br>defined in ISO 10993-1/C1:2010, including parts 3, 5, 10<br>and 11, for permanent medical devices. |
| Bench Testing | NextDent Denture 3D+ has been tested for conformity with<br>the industry standard ISO 20795-1:2013 Dentistry – Base<br>polymers - Part 1: Denture base polymers. |
| | NextDent Denture 3D+ is compliant to the requirements<br>defined in ISO 20975-1 for Type 4 materials. |
| | The following bench tests are conducted on NextDent<br>Denture 3D+: Ultimate Flexural strength Flexural modulus Water sorption Water solubility Residual monomer Biocompatibility |
| | NextDent Denture 3D+ can be repeatedly and successfully<br>printed on all NextDent 5100 Figure4® printers and<br>complies to all requirements defined in ISO 20975-1 for<br>Type 4 materials. The medical device may be printed with<br>horizontal and vertical orientation independent of the build<br>location in the build space, with the possibility to re-use<br>resin, within 80% accuracy of 100 µm, with an worst-case<br>average product density of 6.39 g/mm, at a temperature<br>range of 18°C to 28°C. |
| Reprocessing, Sterility<br>and Shelf-Life Testing | The device is provided non-sterile.<br><br>From the Shelf life testing, NextDent Denture 3D+ has a<br>shelf life of 2 years. |
| VIII. CONCLUSIONS | NextDent Denture 3D+ and the predicate have the same<br>intended use and similar technological characteristics. |
| | |
| | The results of the performed tests show that NextDent<br>Denture 3D+ meets the requirements mentioned in the<br>applicable standards, and confirm that the device performs<br>similarly to the predicate device. |
| | It is therefore concluded that NextDent Denture 3D+ is safe<br>and performs as intended, and is substantially equivalent to<br>the predicate device. |

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