FDA.reportPublic FDA data

Gradual Dental Zirconia Blank

Primary DI
06941382296947
Brand
Gradual Dental Zirconia Blank
Company
Liaoning Upcera Co.,Ltd.
Model
GT(F)P2-M-A3.5 D98-30
Published
2026-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
06941382296947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941382296947069413822969476941382296947

Regulatory Flags#

DUNS number
548214192
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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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
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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
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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
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