FDA.reportPublic FDA data

Delta Zirconia Translucent

Primary DI
00816795024110
Brand
Delta Zirconia Translucent
Company
AURIDENT INC
Model
D810A3.5T
Device description
98X10mm Translucent Shade 3.5
Published
2016-09-19
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
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141724000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141724000UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANKLiaoning Upcera Co., Ltd.2014-10-22EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816795024110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816795024110008167950241108167950241100816795024110

GMDN Terms#

Term, Definition table
TermDefinition
Dental porcelain/ceramic restoration kitA collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
030580955
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
00816795025445Delta Zirconia Multilayered Translucent DiscD812A1MUL/T2017-03-23
00816795025421Delta Zirconia High Translucent DiscD812C3T2017-03-22
00816795025643Delta Zirconia High Translucent DiscD818D4T2017-03-23
08816795025445Delta Zirconia Multilayered Translucent DiscD812A1MUL/T2017-03-23
00816795024059Delta ZirconiaD810A0G2016-09-15
00816795024080Delta Zirconia TranslucentD810A1T2016-09-19
00816795024097Delta Zirconia TranslucentD810A2T2016-09-19
00816795024103Delta Zirconia TranslucentD810A3T2016-09-19
00816795024127Delta Zirconia TranslucentD810B2T2016-09-19
00816795024134Delta Zirconia TranslucentD810B3T2016-09-19
00816795024141Delta Zirconia TranslucentD810C2T2016-09-19
00816795024158Delta Zirconia TranslucentD810C3T2016-09-19
00816795024165Delta Zirconia TranslucentD810D2T2016-09-19
00816795024172Delta Zirconia D812A0G2016-09-19
00816795024196Delta Zirconia TranslucentD812A0TG2016-09-19
00816795024202Delta Zirconia TranslucentD812A1T2016-09-19
00816795024219Delta Zirconia TranslucentD812A2T2016-09-19
00816795024226Delta Zirconia TranslucentD812A3T2016-09-19
00816795024233Delta Zirconia TranslucentD812A3.5T2016-09-19
00816795024240Delta Zirconia TranslucentD812B2T2016-09-19

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Primary DI, Brand, Company table
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