FDA.report

e-1 Purple 37% phosphoric acid gel etchant

Primary DI
D8918601601
Brand
e-1 Purple 37% phosphoric acid gel etchant
Company
E DENTAL PRODUCTS
Model
8601601
Catalog number
8601601
Device description
2 pack of 30ml Purple 37% phosphoric acid etchant gel kit
Published
2020-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KLEAgent, Tooth Bonding, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D8918601601PrimaryHIBCC0
D8918030Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental etching solutionAn acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Total Volume30Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit75 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
1-844-289-3824sales@edentalproducts.com

Regulatory Flags

DUNS number
081045871
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D8918012006e-1 Purple 37% phosphoric acid gel etchant801200680120062020-02-28
D8918003006e-1 Purple 37% Phosphoric acid gel etchant800300680030062020-01-31
D8918010001e-1 Seafoam 37% Phosphoric acid etchant gel901000190100012020-01-31
D89180110001e-1 Purple 37% phosphoric acid gel etchant801000180100012020-01-31
D8918012024e-1 Purple 37% Phosphoric acid gel etchant801202480120242020-01-31
D8918012144e-2 Purple 37% phosphoric acid gel etchant801214480121442020-01-31
D8918602602e-1 Purple 37% phosphoric acid gel etchant860260286026022020-01-31
D8919003006e-1 Seafoam 37% Phosphoric acid gel etchant900300690030062020-01-31
D8919012006e-1 Seafoam 37% Phosphoric acid gel etchant901200690120062020-01-31
D8919012024e-1 Seafoam 37% Phosphoric acid gel etchant901202490120242020-01-31
D8919012144e-1 Seafoam 37% Phosphoric acid gel etchant901214490121442020-01-31
D8919601601e-1 Seafoam 37% Phosphoric acid gel etchant960160196016012020-01-31
D8919602602e-1 Seafoam 37% Phosphoric acid etchant gel960260296026022020-01-31
D8911003006e-1 Orange 37% Phosphoric acid etchant gel100300610030062018-03-09
D8911010001e-1 Orange 37% Phosphoric acid101000110100012018-03-09
D8911012006e-1 Orange 37% Phosphoric acid etchant gel101200610120062018-03-09
D8911012024e-1 Orange 37% Phosphoric acid etchant gel101202410120242018-03-09
D8911601601e-1 Orange 37% Phosphoric acid etchant gel160160116016012018-03-09
D8911602602e-1 Orange 37% Phosphoric acid etchant gel160260216026022018-03-09
D8912003006e-1 Green 37% Phosphoric acid etchant gel200300620030062018-03-09

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