FDA.reportPublic FDA data

Hydrofluoric Acid Etching Gel

Primary DI
06972220484332
Brand
Hydrofluoric Acid Etching Gel
Company
Rizhao HuGe Biomaterials Company, Ltd.
Model
E9
Catalog number
1.2ml
Published
2025-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain
KLEAgent, Tooth Bonding, Resin
PMEExternal Cleaning Solution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2
KLEAgent, Tooth Bonding, ResinDental2
PMEExternal Cleaning SolutionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242530000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242530000HF-Etchant Hydrofluoric Acid Etching GelRizhao Huge Biomaterials Company, Ltd.2024-12-20KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972220484332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972220484332069722204843326972220484332

GMDN Terms#

Term, Definition table
TermDefinition
Dental tooth-etching solutionAn acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
544452689
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970006744069TopCEM Dual Cure Resin CementAutomixA0/8g/A*10,B2*5/UltraCore2026-04-22
06970006744076TopCEM Dual Cure Resin CementAutomixA1/8g/A*10,B2*5/UltraCore2026-04-22
06970006744083TopCEM Dual Cure Resin CementAutomixA2/8g/A*10,B2*5/UltraCore2026-04-22
06970006744090TopCEM Dual Cure Resin CementAutomixA3/8g/A*10,B2*5/UltraCore2026-04-22
06970006744106TopCEM Dual Cure Resin CementAutomixTR/8g/A*10,B2*5/UltraCore2026-04-22
06970006744113TopCEM Dual Cure Resin CementAutomixOpaque/8g/A*10,B2*5/UltraCore2026-04-22
06970006744120TopCEM Dual Cure Resin CementAutomixWhite/8g/A*10,B2*5/UltraCore2026-04-22
06970006746070TopCEM Vigor SA Self-Adhesive Resin Cement/TR (Translucent)/9g2026-04-22
06970006746087TopCEM Vigor SA Self-Adhesive Resin Cement/A0 (Light+)/9g2026-04-22
06970006746094TopCEM Vigor SA Self-Adhesive Resin Cement/A1 (Light)/9g2026-04-22
06970006746100TopCEM Vigor SA Self-Adhesive Resin Cement/A2 (Medium)/9g2026-04-22
06970006746117TopCEM Vigor SA Self-Adhesive Resin Cement/A3 (Dark)/9g2026-04-22
06970006746124TopCEM Vigor SA Self-Adhesive Resin Cement/White (White Opaque)/9g2026-04-22
06970006746131TopCEM Vigor SA Self-Adhesive Resin Cement/Opaque (Universal Opaque)/9g2026-04-22
06972220489375Enamel Coating ResinW-VSM-Enamel Coating ResinTyoe F/1.5ml*12025-10-27
06972220488972Ceramic Coupling AgentW-VSM5ml2025-10-27
06970006744595TrusFIL Universal Composite RestorativeEA2-4g2025-10-30
06972220489092TrusFIL Universal Composite RestorativeA2-4g2025-10-30
06972220489108TrusFIL Universal Composite RestorativeA3-4g2025-10-30
06972220489115TrusFIL Universal Composite RestorativeA3.5-4g2025-10-30

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Primary DI, Brand, Company table
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