Biodentine XP 200 01C0710

GUDID 03701398101986

Bioactive dentin substitute

SEPTODONT SAS SPECIALITES SEPTODONT

Hygroscopic dental cement
Primary Device ID03701398101986
NIH Device Record Keya89e0184-9e2a-4934-9136-5e5f18e0f571
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiodentine XP 200
Version Model Number01C0710
Catalog Number01C0710
Company DUNS275273795
Company NameSEPTODONT SAS SPECIALITES SEPTODONT
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
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 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Moisture

Device Identifiers

Device Issuing AgencyDevice ID
GS103701398101986 [Unit of Use]
GS103701398102136 [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 Date2022-02-15
Device Publish Date2022-02-07

Devices Manufactured by SEPTODONT SAS SPECIALITES SEPTODONT

03760140703335 - BIODENTINE2023-06-13 Bioactive dentin substitute
03760140703366 - BIODENTINE - 5 PACK2023-06-13 Bioactive dentin substitute
03701398102709 - Ultra Safety Plus Twist kit 25G Long2022-10-10 100 needles 25G long (Red) and 1 handle (to be sterilized)
03701398101986 - Biodentine XP 2002022-02-15Bioactive dentin substitute
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 g2022-02-09 Bioactive mineral Root Canal Sealer
33760140704371 - Endosolv2021-01-14 solvent for endodontic cements

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