C-Plast

FDA UDI

Class I (US FDA UDI)

by Candulor AG

Identity

Trade Name: C-PLAST FDA UDI
Generic Name: Dental impression tray material FDA UDI
Device Name: C-Plast Polymer 500g white FDA UDI
Model / Reference: 672719 FDA UDI
Description: C-Plast Polymer 500g white FDA UDI

Identifiers

Catalog Number: 672719 FDA UDI
Primary DI / UDI-DI: 07630813440040 FDA UDI
FDA Product Code: EBH FDA UDI
GMDN Term: Dental impression tray material FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3670 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental impression tray material

C-Plast by Candulor AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Bosworth Fastray LC — Harry J. Bosworth Co. · Class II
OpaTray — OPA DENTAL, LLC · Class I
DURALAY - BLUE — Reliance Dental Manufacturing · Class I
SR Ivolen — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class I

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

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Manufacturer

Manufacturer: Candulor AG

Sources (1)

FDA UDI 05bb043a-82fc-459b-a0fa-79e4ff3f12bf 34 fields · synced May 31, 2026