FDA.reportPublic FDA data

Awesome Dental Products

Primary DI
10850059014124
Brand
Awesome Dental Products
Company
AWESOME DENTAL PRODUCTS, LLC
Model
LTC14BL2
Device description
Milling Blocks Low Translucency C14 BL2
Published
2024-06-17
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
K222513000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222513000Glass CeramicsYilink (Tianjin) Biotechnology Co., Ltd.2023-02-10EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850059014124PrimaryGS10
00850059014127Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005901412410850059014124
00850059014127008500590141278500590141270850059014127

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
119145297
Device count
5
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850059014001Awesome Dental ProductsLTC14A12024-06-17
10850059014018Awesome Dental ProductsLTC14A22024-06-17
10850059014025Awesome Dental ProductsLTC14A32024-06-17
10850059014032Awesome Dental ProductsLTC14A3.52024-06-17
10850059014049Awesome Dental ProductsLTC14A42024-06-17
10850059014056Awesome Dental ProductsLTC14B12024-06-17
10850059014063Awesome Dental ProductsLTC14B22024-06-17
10850059014070Awesome Dental ProductsLTC14C12024-06-17
10850059014087Awesome Dental ProductsLTC14C22024-06-17
10850059014094Awesome Dental ProductsLTC14D22024-06-17
10850059014100Awesome Dental ProductsLTC14D32024-06-17
10850059014117Awesome Dental ProductsLTC14BL12024-06-17
10850059014131Awesome Dental ProductsLTC14BL32024-06-17
10850059014148Awesome Dental ProductsLTC14BL42024-06-17
10850059014155Awesome Dental ProductsHTC14A12024-06-17
10850059014162Awesome Dental ProductsHTC14A22024-06-17
10850059014179Awesome Dental ProductsHTC14A32024-06-17
10850059014186Awesome Dental ProductsHTC14A3.52024-06-17
10850059014193Awesome Dental ProductsHTC14A42024-06-17
10850059014209Awesome Dental ProductsHTC14B12024-06-17

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