FDA.reportPublic FDA data

Porcelain Etch

Primary DI
00883205045003
Brand
Porcelain Etch
Company
ULTRADENT PRODUCTS, INC.
Model
405
Catalog number
405
Device description
Porcelain Etch Kit
Published
2026-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIHPOWDER, PORCELAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205045003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205045003008832050450038832050450030883205045003

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(801)572-4200customerservice@ultradent.com

Regulatory Flags#

DUNS number
013369913
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883205040398Halo Sectional Matrix System588358832026-06-26
00883205040978Halo Sectional Matrix System588258822026-06-26
00883205044617Halo Sectional Matrix System993199312026-06-26
00883205044624Halo Sectional Matrix System993299322026-06-26
00883205044631Halo Sectional Matrix System993399332026-06-26
00883205044648Halo Sectional Matrix System993599352026-06-26
00883205044655Halo Sectional Matrix System993699362026-06-26
00883205040404Halo Sectional Matrix System588458842026-06-25
00883205004550ViscoStat ClearS646S6462018-04-28
00883205103192ViscoStat Clear641064102018-04-28
00883205103208ViscoStat Clear640964092018-04-28
00883205106889ViscoStat Clear640764072018-04-28
00883205106896ViscoStat Clear640864082018-04-28
00883205045775ClearTemp LC351835182026-04-28
00883205045782ClearTemp LCS3518S35182026-04-28
00883205045805Universal Dentin Sealant2662662026-04-28
00883205045904UltraSealS3529S35292026-04-28
00883205045911Peak Universal BondS4554S45542026-04-28
00883205045928Peak Universal BondS4551S45512026-04-28
00883205044990Porcelain Repair110811082026-03-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800121751209Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
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08800121751377Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
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08800121751803Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751810Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751827Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751834Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751889Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751896Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27