FDA.reportPublic FDA data

Gradual Dental Zirconia Blank

Primary DI
06941382291348
Brand
Gradual Dental Zirconia Blank
Company
Liaoning Upcera Co.,Ltd.
Model
GT(F)P1-M-C3 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
06941382291348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941382291348069413822913486941382291348

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.

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
06941382296862Gradual Dental Zirconia BlankLT-M-BL2 D98-182026-09-05
06941382296916Gradual Dental Zirconia BlankGT(F)P2-M-A1 D98-302026-09-05
06941382296923Gradual Dental Zirconia BlankGT(F)P2-M-A2 D98-302026-09-05
06941382296930Gradual Dental Zirconia BlankGT(F)P2-M-A3 D98-302026-09-05
06941382296947Gradual Dental Zirconia BlankGT(F)P2-M-A3.5 D98-302026-09-05
06941382296954Gradual Dental Zirconia BlankGT(F)P2-M-B1 D98-302026-09-05
06941382296961Gradual Dental Zirconia BlankGT(F)P2-M-B2 D98-302026-09-05
06942201762285FLNT TempTD-M-A3 D98-302026-09-05
06942201762377FLNT TempTD-S-A1 D98-352026-09-05
06942201762476FLNT TempTD-M-A2 D98-352026-09-05
06942201774288FLNT TempTD-S-A2 D98-102026-09-05
06942201774387FLNT TempTD-M-A3 D98-102026-09-05
06942201774479FLNT TempTD-S-A1 D98-122026-09-05
06942201774578FLNT TempTD-M-A2 D98-122026-09-05
06942201774769FLNT TempTD-M-A1 D98-142026-09-05
06942201774950FLNT TempTD-M-BL4 D98-162026-09-05
06942201774967FLNT TempTD-M-A4 D98-162026-09-05
06942201774981FLNT TempTD-M-D3 D98-162026-09-05
06942201775056FLNT TempTD-S-A3 D98-182026-09-05
06942201775155FLNT TempTD-M-A3.5 D98-182026-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941382296862Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296916Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296923Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296930Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296947Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296954Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296961Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
08800118648406RazorU&C International Co.,LtdEIH2026-09-04
08800118648413RazorU&C International Co.,LtdEIH2026-09-04
08800118648420RazorU&C International Co.,LtdEIH2026-09-04
08800118648437RazorU&C International Co.,LtdEIH2026-09-04
08800118648444RazorU&C International Co.,LtdEIH2026-09-04
08800118648451RazorU&C International Co.,LtdEIH2026-09-04
08800118648468RazorU&C International Co.,LtdEIH2026-09-04
08800118648475RazorU&C International Co.,LtdEIH2026-09-04
08800118648482RazorU&C International Co.,LtdEIH2026-09-04
08800118648499RazorU&C International Co.,LtdEIH2026-09-04
08800118648505RazorU&C International Co.,LtdEIH2026-09-04
08800118648512RazorU&C International Co.,LtdEIH2026-09-04
08800118648529RazorU&C International Co.,LtdEIH2026-09-04
08800118648536RazorU&C International Co.,LtdEIH2026-09-04
08800118648543RazorU&C International Co.,LtdEIH2026-09-04
08800118648550RazorU&C International Co.,LtdEIH2026-09-04
08800118648567RazorU&C International Co.,LtdEIH2026-09-04
08800118648574RazorU&C International Co.,LtdEIH2026-09-04
08800118648581RazorU&C International Co.,LtdEIH2026-09-04
08800118648598RazorU&C International Co.,LtdEIH2026-09-04
08800118648604RazorU&C International Co.,LtdEIH2026-09-04
08800118648611RazorU&C International Co.,LtdEIH2026-09-04
08800118648628RazorU&C International Co.,LtdEIH2026-09-04