FDA.reportPublic FDA data

Bloomden

Primary DI
06942075423657
Brand
Bloomden
Company
Bloomden Bioceramics (Hunan) Co., Ltd.
Model
98×18 HTP-plus
Published
2026-10-25
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
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
06942075423657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942075423657069420754236576942075423657

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
712529058
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
01694207545069Bloomden95×20 SHTP2026-10-25
06942075423619Bloomden98×10 HTP-plus2026-10-25
06942075423626Bloomden98×12 HTP-plus2026-10-25
06942075423633Bloomden98×14 HTP-plus2026-10-25
06942075423640Bloomden98×16 HTP-plus2026-10-25
06942075423664Bloomden98×20 HTP-plus2026-10-25
06942075423671Bloomden98×22 HTP-plus2026-10-25
06942075423688Bloomden98×25 HTP-plus2026-10-25
06942075423695Bloomden98×30 HTP-plus2026-10-25
06942075423701Bloomden98F×10 HTP-plus2026-10-25
06942075423718Bloomden98F×12 HTP-plus2026-10-25
06942075423725Bloomden98F×14 HTP-plus2026-10-25
06942075423732Bloomden98F×16 HTP-plus2026-10-25
06942075423749Bloomden98F×18 HTP-plus2026-10-25
06942075423756Bloomden98F×20 HTP-plus2026-10-25
06942075423763Bloomden98F×22 HTP-plus2026-10-25
06942075423770Bloomden98F×25 HTP-plus2026-10-25
06942075423787Bloomden98F×30 HTP-plus2026-10-25
06942075423794Bloomden95×10 HTP-plus2026-10-25
06942075423800Bloomden95×12 HTP-plus2026-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
01694207545069BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423619BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423626BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423633BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423640BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423664BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423671BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423688BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423695BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423701BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423718BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423725BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423732BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423749BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423756BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423763BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423770BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423787BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423794BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423800BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423817BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423824BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423831BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423848BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423855BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423862BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423879BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423886BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423893BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423909BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25