FDA.reportPublic FDA data

Amber® Mill Meso

Primary DI
08800057118268
Brand
Amber® Mill Meso
Company
Hass Corporation
Model
Amber Mill Meso C12/W4(S)
Published
2025-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K160102000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160102000Amber Mill Series and Amber Press SeriesHass Corp.2016-07-14EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800057118268PrimaryGS10
08800250995239Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800057118268088000571182688800057118268
08800250995239088002509952398800250995239

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
689848555
Device count
5
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800057118220Amber® Mill MesoAmber Mill Meso C12/W0(S)2025-07-20
08800057118237Amber® Mill MesoAmber Mill Meso C12/W1(S)2025-07-20
08800057118244Amber® Mill MesoAmber Mill Meso C12/W2(S)2025-07-20
08800057118251Amber® Mill MesoAmber Mill Meso C12/W3(S)2025-07-20
08800057118275Amber® Mill MesoAmber Mill Meso C12/A1(S)2025-07-20
08800057118282Amber® Mill MesoAmber Mill Meso C12/A2(S)2025-07-20
08800057118299Amber® Mill MesoAmber Mill Meso C12/A3(S)2025-07-20
08800057118305Amber® Mill MesoAmber Mill Meso C12/A3.5(S)2025-07-20
08800057118312Amber® Mill MesoAmber Mill Meso C12/A4(S)2025-07-20
08800057118329Amber® Mill MesoAmber Mill Meso C12/B1(S)2025-07-20
08800057118336Amber® Mill MesoAmber Mill Meso C12/B2(S)2025-07-20
08800057118343Amber® Mill MesoAmber Mill Meso C12/B3(S)2025-07-20
08800057118350Amber® Mill MesoAmber Mill Meso C12/B4(S)2025-07-20
08800057118367Amber® Mill MesoAmber Mill Meso C12/C1(S)2025-07-20
08800057118374Amber® Mill MesoAmber Mill Meso C12/C2(S)2025-07-20
08800057118381Amber® Mill MesoAmber Mill Meso C12/C3(S)2025-07-20
08800057118398Amber® Mill MesoAmber Mill Meso C12/C4(S)2025-07-20
08800057118404Amber® Mill MesoAmber Mill Meso C12/D2(S)2025-07-20
08800057118411Amber® Mill MesoAmber Mill Meso C12/D3(S)2025-07-20
08800057118428Amber® Mill MesoAmber Mill Meso C12/D4(S)2025-07-20

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