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

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
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
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
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
06942201775179FLNT TempTD-M-D2 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
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
08800118648635RazorU&C International Co.,LtdEIH2026-09-04