FDA.reportPublic FDA data

Dental Etchant (Enamel Conditioner), 1kg Bottle

Primary DI
D83600540
Brand
Dental Etchant (Enamel Conditioner), 1kg Bottle
Company
DENT ZAR, INC.
Model
0054
Catalog number
0054
Device description
Etch Gel-available for bulk purchase-1 kg bottle. Dent Zar’s etch gel is a 37% phosphoric acid solution. • Convenient dispensing system with disposable tips• Easy to wash off• Economical• Colored for precise application• Excellent wetting characteristics• Non-drying• Direct to tooth application with disposable luer-lock tips• Refillable applicator syringes
Published
2016-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
D83600540PrimaryHIBCC0

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
789664455
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D83600400Dental Etchant (Enamel Conditioner), 12g Syringe004000402016-09-04
D83600210Z Bond-Visible Light Cure One-Step Bonding Adhesive002100212016-09-03
D83600500Bonding Agent Visible Light Cure005000502016-09-03
D83610181Bonding Agent (Self-Cure) Part A & Part B101810182016-09-03
D836TKJGX4Polishers120242022-03-08
D836PSLFH9LED Curing Light120232022-03-07
D836QXGZK2Dental Diamond Burs120222022-03-07
D83600080Acorn Nano Micro Hybrid-Syringe Shade A1000800082016-09-02
D83600090Acorn Nano Micro Hybrid-Syringe Shade A2000900092016-09-02
D83600100Acorn Nano Micro Hybrid-Syringe Shade A3001000102016-09-02
D83600110Acorn Nano Micro Hybrid-Syringe Shade B2001100112016-09-02
D83600120Acorn Nano Micro Hybrid-Syringe Shade A4001200122016-09-02
D83600130Acorn Nano Micro Hybrid-Syringe Shade B3001300132016-09-02
D83600140Acorn Nano Micro Hybrid-Syringe Shade C2001400142016-09-02
D83600150Acorn Nano Micro Hybrid-Syringe Shade D3001500152016-09-02
D83600160Acorn Nano Micro Hybrid-Syringe Shade A3.5001600162016-09-02
D83600170Acorn Nano Micro Hybrid-Syringe Shade C3001700172016-09-02
D83600180Acorn Nano Micro Hybrid-Syringe Shade B1001800182016-09-02
D83600190Acorn Nano Micro Hybrid-Syringe Incisal001900192016-09-02
D83600221Acorn Single Dose Caps. Sh. A1002200222016-09-02

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