FDA.reportPublic FDA data

Zirconia Dental Ceramics

Primary DI
06975581884810
Brand
Zirconia Dental Ceramics
Company
Chengdu Besmile Medical Technology Co., Ltd.
Model
BSM-D98×10 ST Preshade A3.5
Published
2025-09-18
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
K170894000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170894000Zirconia Dental CeramicsChengdu Besmile Biotechnology Co., Ltd.2017-08-01EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975581884810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975581884810069755818848106975581884810

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
554494754
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06932195394227Scan bodyPJ-BSM-FH2026-05-29
06932195394999Torque WrenchBSM-BS30-80 (Interval 5) A/B2026-05-29
06932195392322BIORES Dental Implant SystemBSM-ZTG37082026-02-28
06932195392339BIORES Dental Implant SystemBSM-ZTG37102026-02-28
06932195392346BIORES Dental Implant SystemBSM-ZTG37122026-02-28
06932195392353BIORES Dental Implant SystemBSM-ZTG37142026-02-28
06932195392360BIORES Dental Implant SystemBSM-ZTG41082026-02-28
06932195392377BIORES Dental Implant SystemBSM-ZTG41102026-02-28
06932195392384BIORES Dental Implant SystemBSM-ZTG41122026-02-28
06932195392391BIORES Dental Implant SystemBSM-ZTG41142026-02-28
06932195392407BIORES Dental Implant SystemBSM-ZTG43082026-02-28
06932195392414BIORES Dental Implant SystemBSM-ZTG43102026-02-28
06932195392421BIORES Dental Implant SystemBSM-ZTG43122026-02-28
06932195392438BIORES Dental Implant SystemBSM-ZTG43142026-02-28
06932195392445BIORES Dental Implant SystemBSM-ZTG48082026-02-28
06932195392452BIORES Dental Implant SystemBSM-ZTG48102026-02-28
06932195392469BIORES Dental Implant SystemBSM-ZTG48122026-02-28
06932195392476BIORES Dental Implant SystemBSM-ZTG48142026-02-28
06932195392483BIORES Dental Implant SystemBSM-ZTG55082026-02-28
06932195392490BIORES Dental Implant SystemBSM-ZTG55102026-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976581410009Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410016Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410023Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410030Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410047Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410054Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410061Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410078Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
EDDI963011DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963051DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963061DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963071DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963081DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963091DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963161DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963171DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963431DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963441DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963451DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963821DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963831DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963841DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963851DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963861DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963941DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963951DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963961DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963971DD cubeY® HLDental Direkt GmbHEIH2026-06-02
D800FMAA01030Colour Liquid A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28