Estemp Eugenol Temporary Cement

FDA UDI

Class II (US FDA UDI)

by Spident Co., Ltd.

Identity

Trade Name: Estemp Eugenol Temporary Cement FDA UDI
Generic Name: Ethoxy benzoic acid dental cement FDA UDI
Model / Reference: 101-1011 FDA UDI

Identifiers

Catalog Number: 101-1011 FDA UDI
Primary DI / UDI-DI: 08809262954210 FDA UDI
510(k) Number: K100290 FDA UDI
FDA Product Code: EMA FDA UDI
GMDN Term: Ethoxy benzoic acid dental cement FDA UDI

Classification

Device Class: Class II 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

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: Ethoxy benzoic acid dental cement

Estemp Eugenol Temporary Cement by Spident Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K100290 also covers:

Estemp NE Temporary Cement — Spident Co., Ltd.

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: Spident Co., Ltd.

Sources (1)

FDA UDI 4b06e4be-583e-4631-884a-575e542d9e94 34 fields · synced Jun 1, 2026