Biodentine - 5 Pack

FDA UDI

Class II (US FDA UDI)

by Septodont Sas Specialites Septodont

Identity

Trade Name: BIODENTINE - 5 PACK FDA UDI
Generic Name: Hygroscopic dental cement FDA UDI
Device Name: Bioactive dentin substitute FDA UDI
Model / Reference: 01C0605 FDA UDI
Description: Bioactive dentin substitute FDA UDI

Identifiers

Catalog Number: 01C0605 FDA UDI
Primary DI / UDI-DI: 03760140703366 FDA UDI
FDA Product Code: EJK FDA UDI
KIF FDA UDI
GMDN Term: Hygroscopic dental cement FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3250 FDA UDI
872.3820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Hygroscopic dental cement

Biodentine - 5 Pack by Septodont Sas Specialites Septodont — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Avalon Biomed NeoSEALER Flo Professional Kit 4.4 g - SAMPLE — NUSMILE, LTD
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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: Septodont Sas Specialites Septodont

Sources (1)

FDA UDI de74c29c-c608-41f9-8136-afd9e35dc0fe 35 fields · synced Jun 1, 2026