FDA.reportPublic FDA data

Dentitude

Primary DI
06976146411120
Brand
Dentitude
Company
Fuzhou Rick Brown Biomaterials Co. Ltd.
Model
LT-C4/D-13-10
Published
2024-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K230487000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230487000Dental Lithium Disilicate Glass-CeramicFuzhou Rick Brown Biomaterials Co., Ltd.2023-07-03EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26976146411124PackageGS130In Commercial Distribution
06976146411120PrimaryGS10
16976146411127Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697614641112426976146411124
06976146411120069761464111206976146411120
1697614641112716976146411127

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
416486948
Device count
10
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976146411045DentitudeLT-A4/D-13-102024-04-18
06976146411052DentitudeLT-B1/D-13-102024-04-18
06976146411069DentitudeLT-B2/D-13-102024-04-18
06976146411076DentitudeLT-B3/D-13-102024-04-18
06976146411083DentitudeLT-B4/D-13-102024-04-18
06976146411090DentitudeLT-C1/D-13-102024-04-18
06976146411106DentitudeLT-C2/D-13-102024-04-18
06976146411113DentitudeLT-C3/D-13-102024-04-18
06976146411137DentitudeLT-D2/D-13-102024-04-18
06976146411144DentitudeLT-D3/D-13-102024-04-18
06976146411151DentitudeLT-D4/D-13-102024-04-18
06976146411168DentitudeLT-BL1/D-13-102024-04-18
06976146411175DentitudeLT-BL2/D-13-102024-04-18
06976146411182DentitudeLT-BL3/D-13-102024-04-18
06976146411199DentitudeLT-BL4/D-13-102024-04-18
26976146411049DentitudeLT-A4/D-13-102024-04-18
26976146411056DentitudeLT-B1/D-13-102024-04-18
26976146411063DentitudeLT-B2/D-13-102024-04-18
26976146411070DentitudeLT-B3/D-13-102024-04-18
26976146411087DentitudeLT-B4/D-13-102024-04-18

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
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08800118648475RazorU&C International Co.,LtdEIH2026-09-04
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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