BioRoot Flow-0.5 g 01E0500

GUDID 03701398102563

Bioactive mineral Root Canal Sealer

SEPTODONT SAS SPECIALITES SEPTODONT

Hygroscopic dental cement
Primary Device ID03701398102563
NIH Device Record Key13b9f8b4-34fb-422c-a820-00f79113ab42
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioRoot Flow-0.5 g
Version Model Number01E0500
Catalog Number01E0500
Company DUNS275273795
Company NameSEPTODONT SAS SPECIALITES SEPTODONT
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-872-8305
Emailsalesorders@septodont.com
Phone1-800-872-8305
Emailsalesorders@septodont.com
Phone1-800-872-8305
Emailsalesorders@septodont.com
Phone1-800-872-8305
Emailsalesorders@septodont.com
Phone1-800-872-8305
Emailsalesorders@septodont.com
Phone1-800-872-8305
Emailsalesorders@septodont.com
Phone1-800-872-8305
Emailsalesorders@septodont.com
Phone1-800-872-8305
Emailsalesorders@septodont.com
Phone1-800-872-8305
Emailsalesorders@septodont.com
Phone1-800-872-8305
Emailsalesorders@septodont.com
Phone1-800-872-8305
Emailsalesorders@septodont.com
Phone1-800-872-8305
Emailsalesorders@septodont.com
Phone1-800-872-8305
Emailsalesorders@septodont.com
Phone1-800-872-8305
Emailsalesorders@septodont.com
Phone1-800-872-8305
Emailsalesorders@septodont.com
Phone1-800-872-8305
Emailsalesorders@septodont.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture

Device Identifiers

Device Issuing AgencyDevice ID
GS103701398102563 [Primary]

FDA Product Code

KIFResin, Root Canal Filling

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-09
Device Publish Date2022-02-01

Devices Manufactured by SEPTODONT SAS SPECIALITES SEPTODONT

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03701398101986 - Biodentine XP 2002022-02-15 Bioactive dentin substitute
03701398101993 - Biodentine XP 5002022-02-15 Bioactive dentin substitute
03701398102556 - BioRoot Flow- 2 g2022-02-09 Bioactive mineral Root Canal Sealer
03701398102563 - BioRoot Flow-0.5 g2022-02-09Bioactive mineral Root Canal Sealer
03701398102563 - BioRoot Flow-0.5 g2022-02-09 Bioactive mineral Root Canal Sealer
33760140704371 - Endosolv2021-01-14 solvent for endodontic cements

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