SEPTODONT ADHERENCE SC 2-9GM DBL BAR SYR 01C2003

GUDID 00303620000529

SEPTODONT ADHERENCE SC 2-9GM DBL BAR SYR

SEPTODONT, INC

Dental composite resin
Primary Device ID00303620000529
NIH Device Record Keyf979476d-f02b-4f7b-9466-666dd7bf15b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSEPTODONT ADHERENCE SC 2-9GM DBL BAR SYR
Version Model Number01C2003
Catalog Number01C2003
Company DUNS012925513
Company NameSEPTODONT, INC
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

Device Dimensions

Weight9 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100303620000529 [Primary]

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-12

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