Vertex-Dental

FDA UDI

Class II (US FDA UDI)

by Vertex-Dental B.V.

Identity

Trade Name: Vertex-Dental FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: For the manufacturing of artificial teeth, crowns or bridges FDA UDI
Model / Reference: NDJTTHWH01000 FDA UDI
Description: For the manufacturing of artificial teeth, crowns or bridges FDA UDI

Identifiers

Primary DI / UDI-DI: 08720604634198 FDA UDI
510(k) Number: K241071 FDA UDI
FDA Product Code: EBG FDA UDI
PZY FDA UDI
GMDN Term: Dental appliance fabrication material, resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3770 FDA UDI
872.3590 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental appliance fabrication material, resin

Vertex-Dental by Vertex-Dental B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental appliance fabrication material, resin.

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Cleared under the same submission

K241071 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Vertex-Dental B.V.

Sources (1)

FDA UDI 2c51f49d-b584-4911-8480-e67bed21d7fd 34 fields · synced Jun 6, 2026