FDA.reportPublic FDA data

Zirconia Dental Ceramics

Primary DI
06975581885459
Brand
Zirconia Dental Ceramics
Company
Chengdu Besmile Medical Technology Co., Ltd.
Model
BSM-D98×14 ST Preshade 0M2
Published
2025-11-04
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
06975581885459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975581885459069755818854596975581885459

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
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
06942686761223Drill2M34211A2026-08-21
06942686761230Drill3M34291A2026-08-21
06942686761247Drill3M36391A2026-08-21
06942686761254Drill3M34531A2026-08-21
06942686761261Drill3M36531A2026-08-21
06942686761278Drill3M38531A2026-08-21
06942686761285Drill3M34571A2026-08-21
06942686761292Drill3M36571A2026-08-21
06942686761308Drill3M38571A2026-08-21
06942686761315Drill3M34671A2026-08-21
06942686761322Drill3M36671A2026-08-21
06942686761339Drill3M38671A2026-08-21
06942686761346Drill4Z32531A2026-08-21
06942686761353Drill4Z32591A2026-08-21
06942686761360Drill4Z32691A2026-08-21
06942686761377DrillLZ34201A2026-08-21
06942686761384Drill3M36211A2026-08-21
06942686761391Drill4M34311A2026-08-21
06942686761407Drill2M34211A2026-08-21
06942686761414Drill2M36211A2026-08-21

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