Biodentine XP 500 01C0720

GUDID 03701398101993

Bioactive dentin substitute

SEPTODONT SAS SPECIALITES SEPTODONT

Hygroscopic dental cement

• Primary Device ID: 03701398101993
• NIH Device Record Key: 56dd7b96-a589-40dc-98b0-391c023219c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biodentine XP 500
• Version Model Number: 01C0720
• Catalog Number: 01C0720
• Company DUNS: 275273795
• Company Name: SEPTODONT SAS SPECIALITES SEPTODONT
• Device Count: 10
• 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: true
• 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

Customer Support Contacts

• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com
• Phone: 1-800-872-8305
• Email: salesorders@septodont.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Moisture

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701398101993 [Unit of Use]
GS1	03701398102143 [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: 2022-02-15
• Device Publish Date: 2022-02-07

Devices Manufactured by SEPTODONT SAS SPECIALITES SEPTODONT

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• 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: 2022-02-15Bioactive 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