Pac-Dent

FDA UDI

Class II (US FDA UDI)

by Pac-Dent International, Inc.

Identity

Trade Name: Pac-Dent FDA UDI
Generic Name: Temporary dental crown/bridge FDA UDI
Model / Reference: PD-120 FDA UDI

Identifiers

Primary DI / UDI-DI: 00815967021049 FDA UDI
FDA Product Code: EBG FDA UDI
GMDN Term: Temporary dental crown/bridge FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3770 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

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: Temporary dental crown/bridge

Pac-Dent by Pac-Dent International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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VIPI BLOCK — Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. · Class II
IDODENTINE — UNION DENTAL SA · Class II
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Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
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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: Pac-Dent International, Inc.

Sources (1)

FDA UDI 2fea94ec-a684-4c5b-90cd-cae973dc1170 32 fields · synced Jun 8, 2026