FDA.reportPublic FDA data

Delta Zirconia High Translucent Disc

Primary DI
00816795025421
Brand
Delta Zirconia High Translucent Disc
Company
AURIDENT INC
Model
D812C3T
Device description
98X10mm High Translucent Shade C3
Published
2017-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00816795025421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816795025421008167950254218167950254210816795025421

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
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
00816795024110Delta Zirconia TranslucentD810A3.5T2016-09-19
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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