FDA.reportPublic FDA data

Dental Zirconia Pre-Shaded Blank

Primary DI
06970596165442
Brand
Dental Zirconia Pre-Shaded Blank
Company
Liaoning Upcera Co.,Ltd.
Model
S-D3 65-40-22
Published
2019-04-03
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141724000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141724000UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANKLiaoning Upcera Co., Ltd.2014-10-22EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970596165442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970596165442069705961654426970596165442

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
548214192
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
06942201760748FLNT TempTD-M-A1 D98-122026-07-28
06942201760946FLNT TempTD-M-A4 D98-142026-07-28
06942201760960FLNT TempTD-M-D3 D98-142026-07-28
06942201761035FLNT TempTD-S-A3 D98-162026-07-28
06942201761134FLNT TempTD-M-A3.5 D98-162026-07-28
06942201761158FLNT TempTD-M-D2 D98-162026-07-28
06942201761219FLNT TempTD-S-BL1 D98-182026-07-28
06942201761226FLNT TempTD-S-A2 D98-182026-07-28
06942201761325FLNT TempTD-M-A3 D98-182026-07-28
06942201761417FLNT TempTD-S-A1 D98-202026-07-28
06942201761424FLNT TempTD-S-B1 D98-202026-07-28
06942201761516FLNT TempTD-M-A2 D98-202026-07-28
06942201761707FLNT TempTD-M-A1 D98-222026-07-28
06942201761714FLNT TempTD-M-B1 D98-222026-07-28
06942201761806FLNT TempTD-S-A3.5 D98-252026-07-28
06942201761899FLNT TempTD-M-BL4 D98-252026-07-28
06942201761998FLNT TempTD-S-A3 D98-282026-07-28
06942201762186FLNT TempTD-S-A2 D98-302026-07-28
06942201747329FLNT TempTD-M-C4 D98-162026-05-26
06942201747398FLNT TempTD-S-A1 D98-182026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06979046196401AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
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06979046196470AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196753AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196821AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
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06979046196845AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
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06979046196920AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196937AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196951AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196968AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
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06979046197019AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197026AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
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06979046197620AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27