BIODENTINE - 5 PACK 01C0605

GUDID 03760140703366

Bioactive dentin substitute

SEPTODONT SAS SPECIALITES SEPTODONT

Hygroscopic dental cement
Primary Device ID03760140703366
NIH Device Record Keyde74c29c-c608-41f9-8136-afd9e35dc0fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIODENTINE - 5 PACK
Version Model Number01C0605
Catalog Number01C0605
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 Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com
Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103760140703366 [Primary]

FDA Product Code

EJKLiner, Cavity, Calcium Hydroxide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-06-13
Device Publish Date2016-09-12

Devices Manufactured by SEPTODONT SAS SPECIALITES SEPTODONT

03760140703335 - BIODENTINE2023-06-13 Bioactive dentin substitute
03760140703366 - BIODENTINE - 5 PACK2023-06-13Bioactive 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 2002022-02-15 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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