XPLEX Bond

FDA UDI

Class II (US FDA UDI)

by Candulor AG

Identity

Trade Name: XPLEX Bond FDA UDI
Generic Name: Denture base resin kit FDA UDI
Device Name: XPLEX Bond FDA UDI
Model / Reference: 756225 FDA UDI
Description: XPLEX Bond FDA UDI

Identifiers

Catalog Number: 756225 FDA UDI
Primary DI / UDI-DI: E1997562251 FDA UDI
FDA Product Code: EBI FDA UDI
GMDN Term: Denture base resin kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3760 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Category: Denture base resin kit

XPLEX Bond by Candulor AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Denture base resin kit.

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Dentorium — Wright Health Group , Ltd. · Class II
ProBase — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class II
ProBase Hot / ProBase Cold — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class II
Dentorium — Wright Health Group , Ltd. · 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 II	Pending data

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Manufacturer

Manufacturer: Candulor AG

Sources (1)

FDA UDI c8e9f0dd-31d6-4158-8126-62f74177ac94 34 fields · synced Jun 1, 2026