FDA.reportPublic FDA data

Delta Zirconia High Translucent Disc

Primary DI
00816795025643
Brand
Delta Zirconia High Translucent Disc
Company
AURIDENT INC
Model
D818D4T
Device description
98X18mm High Translucent Shade D4
Published
2017-03-23
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
00816795025643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816795025643008167950256438167950256430816795025643

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E235P08380VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08390VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08580VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08590VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08610VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08620VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08630VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08640VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08650VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08660VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08670VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08680VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08690VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08710VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08720VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
E235P08730VINTAGE PRIME PRESSSHOFU DENTAL CORPORATIONEIH2026-07-17
06942508892586ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06942508892593ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06976691250007ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06976691250014ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501003ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501010ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501027ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501034ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501041ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501058ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501065ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501072ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
07615208543582IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543599IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07