FDA.reportPublic FDA data

Zirconia Dental Ceramics

Primary DI
06942686762831
Brand
Zirconia Dental Ceramics
Company
Chengdu Besmile Medical Technology Co., Ltd.
Model
BSM-D98×16 STML 3R1.5
Published
2026-10-29
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
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
06942686762831PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942686762831069426867628316942686762831

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
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
06942686762657Zirconia Dental CeramicsBSM-D98×16 STML A3.52026-10-29
06942686762664Zirconia Dental CeramicsBSM-D98×16 STML A42026-10-29
06942686762671Zirconia Dental CeramicsBSM-D98×16 STML B12026-10-29
06942686762688Zirconia Dental CeramicsBSM-D98×16 STML B22026-10-29
06942686762695Zirconia Dental CeramicsBSM-D98×16 STML B32026-10-29
06942686762701Zirconia Dental CeramicsBSM-D98×16 STML B42026-10-29
06942686762718Zirconia Dental CeramicsBSM-D98×16 STML C12026-10-29
06942686762725Zirconia Dental CeramicsBSM-D98×16 STML C22026-10-29
06942686762732Zirconia Dental CeramicsBSM-D98×16 STML C32026-10-29
06942686762749Zirconia Dental CeramicsBSM-D98×16 STML C42026-10-29
06942686762756Zirconia Dental CeramicsBSM-D98×16 STML D22026-10-29
06942686762763Zirconia Dental CeramicsBSM-D98×16 STML D32026-10-29
06942686762770Zirconia Dental CeramicsBSM-D98×16 STML D42026-10-29
06942686762787Zirconia Dental CeramicsBSM-D98×16 STML 2M22026-10-29
06942686762794Zirconia Dental CeramicsBSM-D98×16 STML 2M32026-10-29
06942686762800Zirconia Dental CeramicsBSM-D98×16 STML 2R1.52026-10-29
06942686762817Zirconia Dental CeramicsBSM-D98×16 STML 2R2.52026-10-29
06942686762824Zirconia Dental CeramicsBSM-D98×16 STML 3M22026-10-29
06942686762848Zirconia Dental CeramicsBSM-D98×16 STML 0M12026-10-29
06942686762855Zirconia Dental CeramicsBSM-D98×16 STML 0M22026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942686762657Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762664Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762671Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762688Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762695Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762701Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762718Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762725Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762732Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762749Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762756Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762763Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762770Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762787Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762794Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762800Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762817Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762824Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762848Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762855Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762862Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762879Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762886Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762893Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762909Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762916Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762923Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762930Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762947Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29
06942686762954Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-10-29