FDA.reportPublic FDA data

VINTAGE OPAL

Primary DI
E23569040
Brand
VINTAGE OPAL
Company
SHOFU DENTAL CORPORATION
Model
6904
Catalog number
6904
Device description
VINTAGE OPAL STARTER KIT B3
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
ELLTEETH, PORCELAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELLTeeth, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K884214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K884214000CRYSTAR(TM) VINTAGE PORCELAINShofu Dental Corp.1988-12-08ELL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E23569040PrimaryHIBCC0

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
E235DZ9812A10DENTADISC ZRDZ9812A1DZ9812A12026-08-23
E235DZ9812A20DENTADISC ZRDZ9812A2DZ9812A22026-08-23
E235DZ9812A30DENTADISC ZRDZ9812A3DZ9812A32026-08-23
E235DZ9812A350DENTADISC ZRDZ9812A35DZ9812A352026-08-23
E235DZ9812B10DENTADISC ZRDZ9812B1DZ9812B12026-08-23
E235DZ9812B20DENTADISC ZRDZ9812B2DZ9812B22026-08-23
E235DZ9812C10DENTADISC ZRDZ9812C1DZ9812C12026-08-23
E235DZ9812C20DENTADISC ZRDZ9812C2DZ9812C22026-08-23
E235DZ9812C30DENTADISC ZRDZ9812C3DZ9812C32026-08-23
E235DZ9812D20DENTADISC ZRDZ9812D2DZ9812D22026-08-23
E235DZ9812D30DENTADISC ZRDZ9812D3DZ9812D32026-08-23
E235DZ9814A10DENTADISC ZRDZ9814A1DZ9814A12026-08-23
E235DZ9814A20DENTADISC ZRDZ9814A2DZ9814A22026-08-23
E235DZ9814A30DENTADISC ZRDZ9814A3DZ9814A32026-08-23
E235DZ9814A350DENTADISC ZRDZ9814A35DZ9814A352026-08-23
E235DZ9814B10DENTADISC ZRDZ9814B1DZ9814B12026-08-23
E235DZ9814B20DENTADISC ZRDZ9814B2DZ9814B22026-08-23
E235DZ9814BL10DENTADISC ZRDZ9814BL1DZ9814BL12026-08-23
E235DZ9814BL20DENTADISC ZRDZ9814BL2DZ9814BL22026-08-23
E235DZ9814BL30DENTADISC ZRDZ9814BL3DZ9814BL32026-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979878380078Jiahong dental labShenzhen Jiahong Dental Technology Co.,Ltd.ELL2026-04-03
06975409640055ZrcoopHangzhou Thales Medtech Co., Ltd.ELL2025-01-03
06975409640062ZrcoopHangzhou Thales Medtech Co., Ltd.ELL2025-01-03
06975409640079ZrcoopHangzhou Thales Medtech Co., Ltd.ELL2025-01-03
06975409641007ZrcoopHangzhou Thales Medtech Co., Ltd.ELL2025-01-03
E23561010VINTAGESHOFU DENTAL CORPORATIONELL2021-02-03
E23561020VINTAGESHOFU DENTAL CORPORATIONELL2021-02-03
E23566850VINTAGE MARGINSHOFU DENTAL CORPORATIONELL2021-02-03
E23569010VINTAGE OPALSHOFU DENTAL CORPORATIONELL2021-02-03
E23569050VINTAGE OPALSHOFU DENTAL CORPORATIONELL2021-02-03
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07332747179590NobelProcera®Nobel Biocare ABELL2020-12-11
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07332747179613NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179620NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179637NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179644NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179651NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179668NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179675NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179682NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179699NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179705NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179712NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179729NobelProcera®Nobel Biocare ABELL2020-12-11
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07332747179743NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179750NobelProcera®Nobel Biocare ABELL2020-12-11