Biodentine Applicator (Gun) 01C0730

GUDID 03701398108510

Device for extrusion of dentine substitute.

SEPTODONT SAS SPECIALITES SEPTODONT

Dental material cartridge-plunging applicator, single-component

• Primary Device ID: 03701398108510
• NIH Device Record Key: d8ca8024-feb8-40fa-95b5-fe71c4d66777
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biodentine Applicator (Gun)
• Version Model Number: 01C0730
• Catalog Number: 01C0730
• Company DUNS: 275273795
• Company Name: SEPTODONT SAS SPECIALITES SEPTODONT
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701398108503 [Primary]
GS1	03701398108510 [Direct Marking]

FDA Product Code

• EJB: Handle, Instrument, Dental

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[03701398108510]

Moist Heat or Steam Sterilization

[03701398108510]

Moist Heat or Steam Sterilization

[03701398108510]

Moist Heat or Steam Sterilization

[03701398108510]

Moist Heat or Steam Sterilization

[03701398108510]

Moist Heat or Steam Sterilization

[03701398108510]

Moist Heat or Steam Sterilization

[03701398108510]

Moist Heat or Steam Sterilization

[03701398108510]

Moist Heat or Steam Sterilization

[03701398108510]

Moist Heat or Steam Sterilization

[03701398108510]

Moist Heat or Steam Sterilization

[03701398108510]

Moist Heat or Steam Sterilization

[03701398108510]

Moist Heat or Steam Sterilization

[03701398108510]

Moist Heat or Steam Sterilization

[03701398108510]

Moist Heat or Steam Sterilization

[03701398108510]

Moist Heat or Steam Sterilization

[03701398108510]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-09
• Device Publish Date: 2024-12-01

Devices Manufactured by SEPTODONT SAS SPECIALITES SEPTODONT

• 03701398108510 - Biodentine Applicator (Gun): 2024-12-09Device for extrusion of dentine substitute.
• 03701398108510 - Biodentine Applicator (Gun): 2024-12-09 Device for extrusion of dentine substitute.
• 03760140703335 - BIODENTINE: 2023-06-13 Bioactive dentin substitute
• 03760140703366 - BIODENTINE - 5 PACK: 2023-06-13 Bioactive dentin substitute
• 03701398102709 - Ultra Safety Plus Twist kit 25G Long: 2022-10-10 100 needles 25G long (Red) and 1 handle (to be sterilized)
• 03701398101986 - Biodentine XP 200: 2022-02-15 Bioactive dentin substitute
• 03701398101993 - Biodentine XP 500: 2022-02-15 Bioactive dentin substitute
• 03701398102556 - BioRoot Flow- 2 g: 2022-02-09 Bioactive mineral Root Canal Sealer
• 03701398102563 - BioRoot Flow-0.5 g: 2022-02-09 Bioactive mineral Root Canal Sealer