FDA.reportPublic FDA data

Etch Gel (12 grams) with 25 tips

Primary DI
D876936060
Brand
Etch Gel (12 grams) with 25 tips
Company
ALMORE INTERNATIONAL INC
Model
93606
Catalog number
93606
Device description
Etch Gel is a high viscosity enamel etching agent used for bonding purposes. It represents a 33% solution of ortho-phosphoric acid, thickened with a combination of water soluble and water dispersible agents. Simple to wash out and clean. Tinted for application control. Includes 1 Etch Gel Syringe (12 grams) and 25 applicator tips.
Published
2019-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D876936060PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009051723
Device count
1
Lot or batch
true

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Primary DI, Brand, Model table
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