Bio-C Temp

FDA UDI

Class II (US FDA UDI)

by Angelus Industria de Produtos Odontologicos S A

Identity

Trade Name: BIO-C TEMP FDA UDI
Generic Name: Endodontic filling/sealing material FDA UDI
Device Name: Ready-to-use Bioceramic Paste for Intracanal Dressing - BIO-C TEMP 0.5 g FDA UDI
Model / Reference: BIO-C TEMP 0.5 g FDA UDI
Description: Ready-to-use Bioceramic Paste for Intracanal Dressing - BIO-C TEMP 0.5 g FDA UDI

Identifiers

Catalog Number: 2832 FDA UDI
Primary DI / UDI-DI: 07898078659915 FDA UDI
FDA Product Code: KIF FDA UDI
GMDN Term: Endodontic filling/sealing material FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3820 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: Endodontic filling/sealing material

Bio-C Temp by Angelus Industria de Produtos Odontologicos S A — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Angelus Industria de Produtos Odontologicos S A

Sources (1)

FDA UDI f1f44efa-f4b8-40e9-9503-43c4c33b4c99 35 fields · synced May 30, 2026