FDA.reportPublic FDA data

e-1 Purple 37% Phosphoric acid gel etchant

Primary DI
D8918003006
Brand
e-1 Purple 37% Phosphoric acid gel etchant
Company
E DENTAL PRODUCTS
Model
8003006
Catalog number
8003006
Device description
6 pack of 3ml Purple Phosphoric acid etchant gel
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8918003006PrimaryHIBCC0
D8918003Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Total Volume3Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit75 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-844-289-3824sales@edentalproducts.com

Regulatory Flags#

DUNS number
081045871
Device count
6
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8918012006e-1 Purple 37% phosphoric acid gel etchant801200680120062020-02-28
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
D8918601601e-1 Purple 37% phosphoric acid gel etchant860160186016012020-01-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815967022503PacBondPac-Dent, Inc.KLE2026-03-24
00815967023005PacBondPac-Dent, Inc.KLE2026-03-24
00815967027454RodinPac-Dent, Inc.KLE2026-03-24
00815967027461RodinPac-Dent, Inc.KLE2026-03-24
00815967027478RodinPac-Dent, Inc.KLE2026-03-24
00815967027485RodinPac-Dent, Inc.KLE2026-03-24
00815967022404PacEtchPac-Dent, Inc.KLE2026-03-23
00815967022411PacEtchPac-Dent, Inc.KLE2026-03-23
00815967022589PacEtchPac-Dent, Inc.KLE2026-03-23
00815967029984RodinPac-Dent, Inc.KLE2026-03-23
DVIV687778WW0Adhese Universal DCIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2026-03-17
DVIV687779WW0Adhese Universal DCIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2026-03-17
07290115050196Prima Quick PrimeB.J.M. LABORATORIES LTDKLE2026-03-13
07290115051889Smile Stream STEP-1 PumEtchB.J.M. LABORATORIES LTDKLE2026-03-13
00840479203409SELF ETCHING PRIMER REFILL CARTRIDGERELIANCE ORTHODONTIC PRODUCTS INCKLE2026-03-12
00840479203546ASSURE PLUS ALL SURFACE RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-03-12
00840481135286MICROPRIMEZest Anchors, LLCKLE2026-03-10
00840481135293MICROPRIMEZest Anchors, LLCKLE2026-03-10
00840479200767ASSURE UNIVERSAL BONDING RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-23
00840479200859BLUE ETCH GEL WITH BACRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-23
00840479200897ASSURE UNIVERSAL BONDING RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-23
00840479200781ASSURE PLUS ALL SURFACE RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479200798ASSURE PLUS ALL SURFACE RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479200804ASSURE PLUS ALL SURFACE RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479203591ULTRA SELF ETCHING PRIMERRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479203607ULTRA SELF ETCHING PRIMERRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479200071BLUE ETCH GEL WITH BACRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-18
00840479200088BLUE ETCH GEL WITH BACRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-18
00190746071003Acid EtchantAMERICAN ORTHODONTICS CORPORATIONKLE2026-01-28
00850079280120HexaHexa DentalKLE2026-01-21