FDA.reportPublic FDA data

VINTAGE

Primary DI
E23561010
Brand
VINTAGE
Company
SHOFU DENTAL CORPORATION
Model
6101
Catalog number
6101
Device description
VINTAGE STARTER-KIT A2
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
E23561010PrimaryHIBCC0

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
E235Y00040SHOFU RESIN GLAZEY0004Y00042021-02-03
E235DPC0DentaprintDPCDPC2026-04-29
E235DPM0DentaprintDPMDPM2026-04-29
E235DPOM0DentaprintDPOMDPOM2026-04-29
E235DPSG0DentaprintDPSGDPSG2026-04-29
E235DPTIA10DentaprintDPTIA1DPTIA12026-04-29
E235DPTIA2DentaprintDPTIA2DPTIA22026-04-29
E235DPTIBW0DentaprintDPTIBWDPTIBW2026-04-29
04548162224736GlasIonomer FX ULTRA112511252026-04-10
04548162224743GlasIonomer FX ULTRA112611262026-04-10
04548162224750GlasIonomer FX ULTRA112711272026-04-10
04548162224767GlasIonomer FX ULTRA112811282026-04-10
04548162265111VINTAGE Art UniversalP1695P16952026-04-10
04548162267207VINTAGE Art UniversalP0691P06912026-04-10
04548162267214VINTAGE Art UniversalP0693P06932026-04-10
04548162267221VINTAGE Art UniversalP0692P06922026-04-10
04548162267238VINTAGE Art UniversalP0694P06942026-04-10
04548162267245VINTAGE Art UniversalP0695P06952026-04-10
04548162267252VINTAGE Art UniversalP0696P06962026-04-10
04548162267269VINTAGE Art UniversalP0697P06972026-04-10

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
E23561020VINTAGESHOFU DENTAL CORPORATIONELL2021-02-03
E23566850VINTAGE MARGINSHOFU DENTAL CORPORATIONELL2021-02-03
E23569010VINTAGE OPALSHOFU DENTAL CORPORATIONELL2021-02-03
E23569040VINTAGE OPALSHOFU DENTAL CORPORATIONELL2021-02-03
E23569050VINTAGE OPALSHOFU DENTAL CORPORATIONELL2021-02-03
07332747179569NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179576NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179583NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179590NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179606NobelProcera®Nobel Biocare ABELL2020-12-11
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
07332747179736NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179743NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179750NobelProcera®Nobel Biocare ABELL2020-12-11