FDA.reportPublic FDA data

Zirconia Dental Ceramics

Primary DI
06942686762411
Brand
Zirconia Dental Ceramics
Company
Chengdu Besmile Medical Technology Co., Ltd.
Model
BSM-D98×14 STML A3.5
Published
2026-11-02
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
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
06942686762411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942686762411069426867624116942686762411

Regulatory Flags#

DUNS number
554494754
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
06942686762299Zirconia Dental CeramicsBSM-D98×12 STML D42026-11-02
06942686762305Zirconia Dental CeramicsBSM-D98×12 STML 2M22026-11-02
06942686762312Zirconia Dental CeramicsBSM-D98×12 STML 2M32026-11-02
06942686762329Zirconia Dental CeramicsBSM-D98×12 STML 2R1.52026-11-02
06942686762336Zirconia Dental CeramicsBSM-D98×12 STML 2R2.52026-11-02
06942686762343Zirconia Dental CeramicsBSM-D98×12 STML 3M22026-11-02
06942686762350Zirconia Dental CeramicsBSM-D98×12 STML 3R1.52026-11-02
06942686762367Zirconia Dental CeramicsBSM-D98×12 STML 0M12026-11-02
06942686762374Zirconia Dental CeramicsBSM-D98×12 STML 0M22026-11-02
06942686762381Zirconia Dental CeramicsBSM-D98×12 STML 0M32026-11-02
06942686762398Zirconia Dental CeramicsBSM-D98×14 STML A12026-11-02
06942686762404Zirconia Dental CeramicsBSM-D98×14 STML A22026-11-02
06942686762428Zirconia Dental CeramicsBSM-D98×14 STML A42026-11-02
06942686762435Zirconia Dental CeramicsBSM-D98×14 STML B12026-11-02
06942686762442Zirconia Dental CeramicsBSM-D98×14 STML B22026-11-02
06942686762459Zirconia Dental CeramicsBSM-D98×14 STML B32026-11-02
06942686762466Zirconia Dental CeramicsBSM-D98×14 STML B42026-11-02
06942686762473Zirconia Dental CeramicsBSM-D98×14 STML C12026-11-02
06942686762480Zirconia Dental CeramicsBSM-D98×14 STML C22026-11-02
06942686762497Zirconia Dental CeramicsBSM-D98×14 STML C32026-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942686762299Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762305Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762312Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762329Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762336Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762343Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762350Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762367Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762374Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762381Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762398Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762404Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762428Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762435Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762442Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762459Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762466Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762473Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762480Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762497Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762503Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762510Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762527Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762534Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762541Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762558Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762565Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762572Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762589Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762596Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02