CIMPAT PINK 01E0110

GUDID 03760140703243

Temporary filling material

SEPTODONT SAS SPECIALITES SEPTODONT

Endodontic temporary cement
Primary Device ID03760140703243
NIH Device Record Key01142301-f556-41e9-a303-f09f90fe3f69
Commercial Distribution StatusIn Commercial Distribution
Brand NameCIMPAT PINK
Version Model Number01E0110
Catalog Number01E0110
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 Kitfalse
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
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 Dimensions

Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram

Device Identifiers

Device Issuing AgencyDevice ID
GS103760140703243 [Primary]

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-09-22
Device Publish Date2016-09-12

Devices Manufactured by SEPTODONT SAS SPECIALITES SEPTODONT

03760140703359 - RACEGEL2025-04-03 Thermo-gelifiable gel for gingival preparation
07897990328435 - SeptoWedges Refill: 100 Asst. wooden wedges2025-03-12 wooden wedges
07897990328459 - SeptoMatrix Sectional Refill: 50 assorted matrices2025-03-12 Preformed sectional matrices systems for Class II restorations.
07897990328466 - SeptoMatrix Sectional Refill: 50 large matrices2025-03-12 Preformed sectional matrices systems for Class II restorations.
07897990328473 - SeptoMatrix Sectional Refill: 50 medium matrices2025-03-12 Preformed sectional matrices systems for Class II restorations.
07897990328480 - SeptoMatrix Sectional Refill: 50 small matrices2025-03-12 Preformed sectional matrices systems for Class II restorations.
07897990328718 - SeptoPlus Mandrel Refill: 1 mandrel snap2025-03-12 Mandrel for contra angle
07897990328725 - SeptoDiscs Kit: 120 assorted abrasive discs+ mandrel pop-on2025-03-12 Finishing and polishing discs for composites

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