Vertex-Dental BV

FDA UDI

Class I (US FDA UDI)

by Vertex-Dental B.V.

Identity

Trade Name: Vertex-Dental BV FDA UDI
Generic Name: Temporary dental crown/bridge resin FDA UDI
Device Name: For the manufacturing of crowns and bridges FDA UDI
Model / Reference: NDCMBL01000_1 FDA UDI
Description: For the manufacturing of crowns and bridges FDA UDI

Identifiers

Primary DI / UDI-DI: 08719425508924 FDA UDI
FDA Product Code: ELK FDA UDI
ELJ FDA UDI
GMDN Term: Temporary dental crown/bridge resin FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3910 FDA UDI
872.3900 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Temporary dental crown/bridge resin

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

Similar devices

Also classified as Temporary dental crown/bridge resin.

Alpha-Crown® — Dental Technologies, Inc. · Class II
JET TOOTH SHADE POWDER — Lang Dental Manufacturing Company, Inc. · Class II
UNIFAST™ — Gc America Inc. · Class II
MODIFYING STAIN — AMERICAN TOOTH INDUSTRIES · Class II
DENTURE BASE — AMERICAN TOOTH INDUSTRIES · Class II
PORTUX CAD/CAM Disc. 98.5X 25mm C2. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
tempofit premium BL — DETAX GmbH · Class II
YAMAHACHI PMMA DISK — YAMAHACHI DENTAL MFG., CO. · Class II

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Vertex-Dental B.V.

Sources (1)

FDA UDI c5ef7f32-d59d-49fc-aec7-e3531527bd90 33 fields · synced Jun 6, 2026