FDA.reportPublic FDA data

Bloomden

Primary DI
16974564882383
Brand
Bloomden
Company
Bloomden Bioceramics (Hunan) Co., Ltd.
Model
98×18 ST-C-D3
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
16974564882383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697456488238316974564882383

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
D800ZRTA09010Prettau 5 98H10ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09110Prettau 5 98H14 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09210Prettau 5 98H18 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09310Prettau 5 98H20 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09410Prettau 5 98H12 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09510Prettau 5 98H22 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09620Prettau 5 98H16 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09710Prettau 5 98H25 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106100Prettau 5 106H10ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106110Prettau 5 106H11ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106120Prettau 5 106H12ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106130Prettau 5 106H13ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106140Prettau 5 106H14ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106150Prettau 5 106H15ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106160Prettau 5 106H16ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106170Prettau 5 106H17ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106180Prettau 5 106H18ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106190Prettau 5 106H19ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106200Prettau 5 106H20ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106210Prettau 5 106H21ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106220Prettau 5 106H22ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106230Prettau 5 106H23ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106240Prettau 5 106H24ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106250Prettau 5 106H25ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106260Prettau 5 106H26ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106270Prettau 5 106H27ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106280Prettau 5 106H28ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106290Prettau 5 106H29ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106300Prettau 5 106H30ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106310Prettau 5 106H31ZIRKONZAHN SRLEIH2026-09-18