FDA.reportPublic FDA data

Bloomden

Primary DI
16942075421469
Brand
Bloomden
Company
Bloomden Bioceramics (Hunan) Co., Ltd.
Model
92×75×20 UT-ML-BL2
Published
2025-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K212765000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212765000Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd.2021-11-15EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16942075421469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1694207542146916942075421469

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
712529058
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942075418929Bloomden95×10 UT-ML-A3.52025-07-21
06942075418936Bloomden95×10 UT-ML-A42025-07-21
06942075418943Bloomden95×10 UT-ML-B12025-07-21
06942075418950Bloomden95×10 UT-ML-B22025-07-21
06942075418967Bloomden95×10 UT-ML-B32025-07-21
06942075418974Bloomden95×10 UT-ML-B42025-07-21
06942075418981Bloomden95×10 UT-ML-C12025-07-21
06942075418998Bloomden95×10 UT-ML-C22025-07-21
06942075419001Bloomden95×10 UT-ML-C32025-07-21
06942075419018Bloomden95×10 UT-ML-C42025-07-21
06942075419025Bloomden95×10 UT-ML-D22025-07-21
06942075419032Bloomden95×10 UT-ML-D32025-07-21
06942075419049Bloomden95×10 UT-ML-D42025-07-21
06942075419056Bloomden95×10 UT-ML-BL12025-07-21
06942075419063Bloomden95×10 UT-ML-BL22025-07-21
06942075419070Bloomden95×10 UT-ML-BL32025-07-21
06942075419087Bloomden95×10 UT-ML-BL42025-07-21
06942075419148Bloomden95×12 UT-ML-B12025-07-21
06942075419155Bloomden95×12 UT-ML-B22025-07-21
06942075419162Bloomden95×12 UT-ML-B32025-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800121750769Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750776Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750806Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750837Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750844Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750875Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750882Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750899Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751117Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751124Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751131Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751148Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751193Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751209Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751254Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751261Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751278Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751285Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751339Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751346Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751353Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751360Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751377Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751384Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751803Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751810Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751827Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751834Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751889Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751896Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27