DiaPrep Pro 2002-4100

GUDID 08806383560412

DiaPrep Pro is an EDTA cream with Urea Hydrogen Peroxide, used as an irrigation agent for chemomechanical preparation of the root canal

DiaDent Group International

Root canal cleaning solution
Primary Device ID08806383560412
NIH Device Record Keyb9172c92-5da6-497d-9aa7-2849b968519d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiaPrep Pro
Version Model Number6g
Catalog Number2002-4100
Company DUNS687789453
Company NameDiaDent Group International
Device Count1
DM Exempttrue
Pre-market Exempttrue
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

Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Keep away from Sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS108806383560412 [Primary]

FDA Product Code

EKQPreparer, Root Canal Endodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-04
Device Publish Date2023-06-26

Devices Manufactured by DiaDent Group International

08806383586313 - DUO-GUN2025-03-20 Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable vertical injection of softened Gut
08806383586320 - DUO-PEN2025-03-20 Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root canal filling material(Gutta Perch
08806383534758 - GUTTA PERCHA OBTURATOR2023-07-05 GUTTA PERCHA OBTURATOR is used to root canal filing material.
08806383551014 - Endo Shaping Blocks2023-07-05 Clear acrylic blocks with high transparency for new technique training.
08806383565608 - DISPOSABLE TIPS2023-07-05 Disposable Tip for DiaFil Flow
08806383565615 - DISPOSABLE TIPS2023-07-05 Disposable Tips for DiaEtch
08806383565660 - DISPOSABLE TIPS2023-07-05 Disposable Tips for DiaFil Flow
08806383565677 - DISPOSABLE TIPS2023-07-05 Disposable Tips for DiaEtch

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