FDA.reportPublic FDA data

Dentitude

Primary DI
26976146411070
Brand
Dentitude
Company
Fuzhou Rick Brown Biomaterials Co. Ltd.
Model
LT-B3/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
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
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
26976146411070PackageGS130In Commercial Distribution
06976146411076PrimaryGS10
16976146411073Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697614641107026976146411070
06976146411076069761464110766976146411076
1697614641107316976146411073

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
416486948
Device count
10
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
false
Expiration date on label
false
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
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
06976146411120DentitudeLT-C4/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
26976146411087DentitudeLT-B4/D-13-102024-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979046195251AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196036AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196234AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196333AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196364AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196401AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196463AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196470AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196753AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196821AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196838AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196845AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196852AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196869AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196913AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196920AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196937AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196951AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196968AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196975AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197002AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197019AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197026AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197033AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197057AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197064AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197255AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197279AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197491AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197620AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27