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Biodentine Applicator (Gun)

FDA UDI

Class I (US FDA UDI)

by Septodont Sas Specialites Septodont

Identity

Trade Name
Biodentine Applicator (Gun) FDA UDI
Generic Name
Dental material cartridge-plunging applicator, single-component FDA UDI
Device Name
Device for extrusion of dentine substitute FDA UDI
Model / Reference
01C0730 FDA UDI
Description
Device for extrusion of dentine substitute FDA UDI

Identifiers

Catalog Number
01C0730 FDA UDI
Primary DI / UDI-DI
03701398101894 FDA UDI
FDA Product Code
EJB FDA UDI
GMDN Term
Dental material cartridge-plunging applicator, single-component FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental material cartridge-plunging applicator, single-component

Biodentine Applicator (Gun) by Septodont Sas Specialites Septodont — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental material cartridge-plunging applicator, single-component.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Septodont Sas Specialites Septodont

Sources (1)

  • FDA UDI 9eadf648-9ddf-4f08-9d37-786ba812160b 34 fields · synced Jun 8, 2026