DIAETCH A2001-3101

GUDID 08806383565158

Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine.

DiaDent Group International

Dental etching solution
Primary Device ID08806383565158
NIH Device Record Key8d67def0-97de-4ac7-ae6c-2e8608727f06
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIAETCH
Version Model NumberEconomic Package Type A
Catalog NumberA2001-3101
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

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
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108806383565158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-04
Device Publish Date2020-02-25

On-Brand Devices [DIAETCH]

08806383565196Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine.
08806383565172Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine.
08806383565158Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine.

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