Biodentine Applicator (Gun)

Basic Information

• Brand Name: Biodentine Applicator (Gun)
• Primary DI: 03701398101894
• Version / Model: 01C0730
• Catalog Number: 01C0730
• Company Name: SEPTODONT SAS SPECIALITES SEPTODONT
• Labeler DUNS: 275273795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-13
• Public Version: 1
• Public Version Date: 2022-12-21
• Public Version Status: New
• Public Device Record Key: 9eadf648-9ddf-4f08-9d37-786ba812160b

Device Description

Device for extrusion of dentine substitute

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJB	Handle, Instrument, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16196	Dental material cartridge-plunging applicator, single-component	A hand-held manual device intended to dispense a single-component dental material (not included) from a cartridge directly into the mouth; it is not intended to dispense more than one component simultaneously. It is typically a pistol-like device with a cartridge-plunging mechanism. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03701398101894	GS1
Package	03701398102730	GS1	unit of sale	1	In Commercial Distribution