FDA.reportPublic FDA data

Vintage ZR

Primary DI
E23591950
Brand
Vintage ZR
Company
SHOFU DENTAL CORPORATION
Model
9195
Catalog number
9195
Device description
VINTAGE ZR TRANS CT-B 50g
Published
2016-09-24
Public version status
Update
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
E23591950PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature1 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
760-566-3528ckaemmerlen@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
04548162373847AccuMix Ampule MixerE0006E00062026-07-17
E235P08380VINTAGE PRIME PRESSP0838P08382026-07-17
E235P08390VINTAGE PRIME PRESSP0839P08392026-07-17
E235P08580VINTAGE PRIME PRESSP0858P08582026-07-17
E235P08590VINTAGE PRIME PRESSP0859P08592026-07-17
E235P08610VINTAGE PRIME PRESSP0861P08612026-07-17
E235P08620VINTAGE PRIME PRESSP0862P08622026-07-17
E235P08630VINTAGE PRIME PRESSP0863P08632026-07-17
E235P08640VINTAGE PRIME PRESSP0864P08642026-07-17
E235P08650VINTAGE PRIME PRESSP0865P08652026-07-17
E235P08660VINTAGE PRIME PRESSP0866P08662026-07-17
E235P08670VINTAGE PRIME PRESSP0867P08672026-07-17
E235P08680VINTAGE PRIME PRESSP0868P08682026-07-17
E235P08690VINTAGE PRIME PRESSP0869P08692026-07-17
E235P08710VINTAGE PRIME PRESSP0871P08712026-07-17
E235P08720VINTAGE PRIME PRESSP0872P08722026-07-17
E235P08730VINTAGE PRIME PRESSP0873P08732026-07-17
E235DD16A1ML0DENTADISCDD16A1MLDD16A1ML2026-07-09
E235DD16A1MN0DENTADISCDD16A1MNDD16A1MN2026-07-09
E235DD16A2ML0DENTADISCDD16A2MLDD16A2ML2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942629805106Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805113Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805120Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805137Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805144Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805151Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805168Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805175Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805182Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805199Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805205Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805212Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629805250Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629808985Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809005Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809012Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809029Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809036Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809043Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809074Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809098Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809104Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809111Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809128Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629809135Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-30
06942629808732Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29
06942629808749Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29
06942629808756Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29
06942629808763Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29
06942629808770Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-29