NextDent Jet Denture Base - NextDent Jet Denture Base

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

NextDent Jet Teeth EUDAMED

Vertex-Dental GUDID

Generic Name

Dental appliance fabrication material, resin

Model / Reference

NDJTTHYE01000, Crown & Bridge, Photo-curing resin

Primary DI / UDI-DI

08720604634204

Basic UDI-DI

871942550CBPC10BS

510(k) Number

K241071 ↗

FDA Product Code

EBI 510(k)

EBG GUDID

PZY GUDID

EMDN Code

Q0102050199 Dentistry resins - other

GMDN Term

Dental appliance fabrication material, resin

Models / Variants

NextDent Jet Denture Base

NextDent Jet Denture Teeth

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 872.3760 510(k)

872.3770 GUDID

872.3590 GUDID

EU market of registration

Netherlands

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• Vertex-Dental BV CHC20P05GDS50000

  Class II

  GUDID on market

• Vertex-Dental BV CHC20P20GDS50000

  Class II

  GUDID on market

• Vertex-Dental BV CHC20P03GDS50000

  Class II

  GUDID on market

• Vertex-Dental BV CHC20P17GDS50000

  Class II

  GUDID on market

• Vertex-Dental BV CHC20P04GDS50000

  Class II

  GUDID on market

• Vertex-Dental BV CHC20P10GDS50000

  Class II

  GUDID on market

See all devices from Vertex-Dental B.V. →

• What types of dental facilities can use the NextDent Jet Denture Base and Teeth, and how is it supplied?

  The NextDent Jet Denture Base and Teeth are designed for dental laboratories or clinics that utilize digital printing technology to fabricate custom removable dentures. They are supplied as a reusable set of materials, meaning the components themselves are not single-use but are part of a workflow that produces custom dentures for patients. The system relies on the manufacturer’s digital workflow to determine sizes and configurations, so no additional sizing tools are included in the kit.

• Are the NextDent Jet Denture Base and Teeth sterile, and if not, what cleaning or sterilization steps should be followed?

  The NextDent Jet Denture Base and Teeth are not pre-sterilized as part of their supply. Since they are reusable components for a digital denture fabrication process, they should be handled in accordance with standard dental laboratory protocols to maintain hygiene. While specific sterilization instructions aren’t provided, following established dental cleaning and sterilization procedures—such as autoclaving or chemical disinfection—is recommended to ensure safety and prevent cross-contamination between uses.

• How do I determine if the NextDent Jet Denture Base and Teeth are compatible with my existing digital denture workflow?

  Compatibility depends entirely on the manufacturer’s digital workflow, which is proprietary to Vertex-Dental B.V. The system is designed to integrate with their specific printing process, so you’ll need to confirm that your lab or clinic’s software and hardware align with NextDent’s requirements. Since sizes and configurations are determined digitally rather than physically, ensure your facility has the necessary equipment to generate the correct files for the denture base and teeth components.

• What regulatory approvals does the NextDent Jet Denture Base and Teeth system hold, and how does that affect its use?

  The NextDent Jet Denture Base and Teeth have received FDA 510(k) clearance under the product code EBI, as well as authorizations under the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). These approvals confirm that the system meets regulatory standards for dental devices in the U.S. and EU markets, respectively. Clinicians or labs using this system can rely on these approvals to ensure compliance with applicable regulations, though local laws and additional facility protocols may still apply.