FDA.reportPublic FDA data

VINTAGE ZR

Primary DI
E23592110
Brand
VINTAGE ZR
Company
SHOFU DENTAL CORPORATION
Model
9211
Catalog number
9211
Device description
ZR GUM PORC GUM-V 15G
Published
2021-02-03
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052033000VINTAGE ZRShofu Dental Corp.2005-11-18EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E23592110PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)827-5262customer-service@shofu.com

Regulatory Flags#

DUNS number
054618202
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E235DD16A1ML0DENTADISCDD16A1MLDD16A1ML2026-07-09
E235DD16A1MN0DENTADISCDD16A1MNDD16A1MN2026-07-09
E235DD16A2ML0DENTADISCDD16A2MLDD16A2ML2026-07-09
E235DD16A2MN0DENTADISCDD16A2MNDD16A2MN2026-07-09
E235DD16A35MN0DENTADISCDD16A35MNDD16A35MN2026-07-09
E235DD16A3MN0DENTADISCDD16A3MNDD16A3MN2026-07-09
E235DD16B1ML0DENTADISCDD16B1MLDD16B1ML2026-07-09
E235DD16B1MN0DENTADISCDD16B1MNDD16B1MN2026-07-09
E235DD16B2MN0DENTADISCDD16B2MNDD16B2MN2026-07-09
E235DD16B3MN0DENTADISCDD16B3MNDD16B3MN2026-07-09
E235DD16BL1MN0DENTADISCDD16BL1MNDD16BL1MN2026-07-09
E235DD16BL2MN0DENTADISCDD16BL2MNDD16BL2MN2026-07-09
E235DD16BL3ML0DENTADISCDD16BL3MLDD16BL3ML2026-07-09
E235DD16BL4MN0DENTADISCDD16BL4MNDD16BL4MN2026-07-09
E235DD16BLML0DENTADISCDD16BLMLDD16BLML2026-07-09
E235DD16BLMN0DENTADISCDD16BLMNDD16BLMN2026-07-09
E235DD16C1ML0DENTADISCDD16C1MLDD16C1ML2026-07-09
E235DD16C1MN0DENTADISCDD16C1MNDD16C1MN2026-07-09
E235DD16C2ML0DENTADISCDD16C2MLDD16C2ML2026-07-09
E235DD16C2MN0DENTADISCDD16C2MNDD16C2MN2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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07615208543896IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
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07615208543919IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544039IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544046IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07