SciPharm Eugenone Temporary Cement

FDA UDI

Class II (US FDA UDI)

by Scientific Pharmaceuticals, Inc.

Identity

Trade Name: SciPharm Eugenone Temporary Cement FDA UDI
Generic Name: Glass ionomer dental cement FDA UDI
Device Name: Eugenol Free Temporary Crown and Bridge Cement in Automix Dispensing System. Zinc Oxide Based. ZNO Aliphatic Acid. FDA UDI
Model / Reference: SP 51-501 FDA UDI
Description: Eugenol Free Temporary Crown and Bridge Cement in Automix Dispensing System. Zinc Oxide Based. ZNO Aliphatic Acid. FDA UDI

Identifiers

Catalog Number: 51-501 FDA UDI
Primary DI / UDI-DI: D801SP515011 FDA UDI
510(k) Number: K051952 FDA UDI
FDA Product Code: EMA FDA UDI
GMDN Term: Glass ionomer 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

Yes

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: Glass ionomer dental cement

SciPharm Eugenone Temporary Cement by Scientific Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K051952 also covers:

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: Scientific Pharmaceuticals, Inc.

Sources (1)

FDA UDI 98cd2b7d-5751-40a8-a227-5ae6c10a0bdd 37 fields · synced Jun 1, 2026