ZOE B&T® Base and Temporary Filling Material

FDA UDI

Class I (US FDA UDI)

by Dentsply International

Identity

Trade Name: ZOE B&T® Base and Temporary Filling Material FDA UDI
Generic Name: Zinc oxide eugenol dental cement FDA UDI
Device Name: ZOE B&T® Base and Temporary Filling Material Standard Package FDA UDI
Model / Reference: 610103 FDA UDI
Description: ZOE B&T® Base and Temporary Filling Material Standard Package FDA UDI

Identifiers

Catalog Number: 610103 FDA UDI
Primary DI / UDI-DI: D0026101031 FDA UDI
FDA Product Code: EMB FDA UDI
GMDN Term: Zinc oxide eugenol dental cement FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3275 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

Yes

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

Dimensions & Sizes

Size: Total Volume — 14 Milliliter FDA UDI
Weight — 25 Gram FDA UDI

Category: Zinc oxide eugenol dental cement

ZOE B&T® Base and Temporary Filling Material by Dentsply International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Zonalin Complete Quick Set Pack 28g/10ml — ASSOCIATED DENTAL PRODUCTS LIMITED · 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

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Manufacturer

Manufacturer: Dentsply International

Sources (1)

FDA UDI a7a144a3-6829-45e2-b5fe-967aa4808d26 37 fields · synced May 30, 2026