FDA.reportPublic FDA data

Onyx

Primary DI
00817051020464
Brand
Onyx
Company
CENTRIX, INC.
Model
310053
Device description
Onyx Etch 1.2ml 40% Phosphoric Acid Etching Gel, 6 syringes
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K890140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K890140000PHOSPHORIC-ACID ETCHING GELCentrix, Inc.1989-03-29EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817051020464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817051020464008170510204648170510204640817051020464

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
053707303
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817051020457Onyx3100522016-09-23
00817051020471Onyx3100542016-09-23
00817051020488Onyx3100552016-09-23
00817051023847Fluorodose3601402025-03-17
00817051023854Fluorodose3601432025-03-17
10817051023844Fluorodose3601422025-03-17
20817051023841Fluorodose3601412025-03-17
00817051022963StatStix3800642023-12-29
00817051022970StatStix3800652023-12-29
00817051020303Access Edge3601132016-09-23
00817051020310Access Edge3601142016-09-23
00817051020327Access Flo3601222016-09-23
00817051020334Access Flo3601232016-09-23
00817051021225GingiTrac3600682016-09-23
00817051021232GingiTrac3600692016-09-23
00817051021249GingiTrac3601002016-09-23
00817051021256GingiTrac3601012016-09-23
00817051021263GingiTrac3601022016-09-23
00817051021270GingiTrac7000022016-09-23
00817051020730EveryBond3101122016-09-23

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Primary DI, Brand, Company table
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