Biodentine XP 500 01C0720

GUDID 03701398101993

Bioactive dentin substitute

SEPTODONT SAS SPECIALITES SEPTODONT

Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement 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

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• 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
• 33760140704371 - Endosolv: 2021-01-14 solvent for endodontic cements