DIA-PROSEAL 1003-201

GUDID 08806383551021

DIA-PROSEAL Root Canal Sealer is two-component systems that react via an epoxide/amine chemical reaction to case setting.

DiaDent Group International

Endodontic filling/sealing material
Primary Device ID08806383551021
NIH Device Record Key3d309d94-28a2-431d-b7db-0d176f0cea31
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIA-PROSEAL
Version Model Number16g
Catalog Number1003-201
Company DUNS687789453
Company NameDiaDent Group International
Device Count1
DM Exempttrue
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid expesure to direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS108806383551021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2019-10-10
Device Publish Date2019-10-02

On-Brand Devices [DIA-PROSEAL]

08806383551038DIA-PROSEAL Root Canal Sealer is two-component systems that react via an epoxide/amine chemical
08806383551021DIA-PROSEAL Root Canal Sealer is two-component systems that react via an epoxide/amine chemical

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