FDA.reportPublic FDA data

Gradual Dental Zirconia Blank

Primary DI
06941382291317
Brand
Gradual Dental Zirconia Blank
Company
Liaoning Upcera Co.,Ltd.
Model
GT(F)P1-M-B4 D98-12
Published
2026-04-22
Public version status
New
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
K253973000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253973000Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP SeriesLiaoning Upcera Co., Ltd.2026-01-09EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941382291317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941382291317069413822913176941382291317

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
06942201746810FLNT TempTD-S-BL3 D98-122026-11-03
06942201746827FLNT TempTD-S-A3.5 D98-122026-11-03
06942201746834FLNT TempTD-S-B4 D98-122026-11-03
06942201746841FLNT TempTD-S-D2 D98-122026-11-03
06942201747008FLNT TempTD-S-BL2 D98-142026-11-03
06942201747022FLNT TempTD-S-B3 D98-142026-11-03
06942201747039FLNT TempTD-S-C4 D98-142026-11-03
06942201747107FLNT TempTD-M-BL3 D98-142026-11-03
06942201747121FLNT TempTD-M-B4 D98-142026-11-03
06942201747138FLNT TempTD-M-D2 D98-142026-11-03
06942201747213FLNT TempTD-S-B2 D98-162026-11-03
06942201747220FLNT TempTD-S-C3 D98-162026-11-03
06942201747299FLNT TempTD-M-BL2 D98-162026-11-03
06942201747312FLNT TempTD-M-B3 D98-162026-11-03
06942201747411FLNT TempTD-S-C2 D98-182026-11-03
06942201747428FLNT TempTD-S-D4 D98-182026-11-03
06942201747480FLNT TempTD-M-BL1 D98-182026-11-03
06942201747503FLNT TempTD-M-B2 D98-182026-11-03
06942201747510FLNT TempTD-M-C3 D98-182026-11-03
06942201747602FLNT TempTD-S-C1 D98-202026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J01753654500400CEREC MTL SpeedVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-11-05
J01753654500410CEREC MTL SpeedVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-11-05
J01753654500420CEREC MTL SpeedVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-11-05
J01753654500430CEREC MTL SpeedVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-11-05
J01753654500440CEREC MTL SpeedVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-11-05
06942686762299Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762305Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762312Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762329Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762336Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762343Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762350Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762367Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762374Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762381Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762398Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762404Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762411Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762428Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762435Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762442Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762459Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762466Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762473Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762480Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762497Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762503Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762510Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762527Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762534Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02