FDA.reportPublic FDA data

Bloomden

Primary DI
16974564883335
Brand
Bloomden
Company
Bloomden Bioceramics (Hunan) Co., Ltd.
Model
95×12 ST-C-B3
Published
2024-10-22
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
16974564883335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697456488333516974564883335

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
16942075459585Bloomden95×18 SHTP-C-C12026-10-31
16942075459592Bloomden95×18 SHTP-C-C22026-10-31
16942075459608Bloomden95×18 SHTP-C-C32026-10-31
16942075459615Bloomden95×18 SHTP-C-C42026-10-31
16942075459622Bloomden95×18 SHTP-C-D22026-10-31
16942075459639Bloomden95×18 SHTP-C-D32026-10-31
16942075459646Bloomden95×18 SHTP-C-D42026-10-31
16942075459653Bloomden95×18 SHTP-C-BL12026-10-31
16942075459660Bloomden95×18 SHTP-C-BL22026-10-31
16942075459677Bloomden95×18 SHTP-C-BL32026-10-31
16942075459684Bloomden95×18 SHTP-C-BL42026-10-31
16942075459691Bloomden95×20 SHTP-C-A12026-10-31
16942075459707Bloomden95×20 SHTP-C-A22026-10-31
16942075459714Bloomden95×20 SHTP-C-A32026-10-31
16942075459721Bloomden95×20 SHTP-C-A3.52026-10-31
16942075459738Bloomden95×20 SHTP-C-A42026-10-31
16942075459745Bloomden95×20 SHTP-C-B12026-10-31
16942075459752Bloomden95×20 SHTP-C-B22026-10-31
16942075459769Bloomden95×20 SHTP-C-B32026-10-31
16942075459776Bloomden95×20 SHTP-C-B42026-10-31

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
06942686762411Zirconia 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