Endosolv 01E0400

GUDID 33760140704371

solvent for endodontic cements

SEPTODONT SAS SPECIALITES SEPTODONT

Root canal filling-removal solution

• Primary Device ID: 33760140704371
• NIH Device Record Key: 53722f53-881a-4acf-a654-b5099f6dc5f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endosolv
• Version Model Number: 01E0400
• Catalog Number: 01E0400
• Company DUNS: 275273795
• Company Name: SEPTODONT SAS SPECIALITES SEPTODONT
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: true
• 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	33760140704371 [Primary]

FDA Product Code

• KIF: Resin, Root Canal Filling

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-14
• Device Publish Date: 2021-01-06

Devices Manufactured by SEPTODONT SAS SPECIALITES SEPTODONT

• 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