FDA.reportPublic FDA data

Amber® LiSi-POZ

Primary DI
08800057120254
Brand
Amber® LiSi-POZ
Company
Hass Corporation
Model
Amber LiSi-POZ HT R7/A4
Published
2024-05-06
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
08800057120254PrimaryGS10
08800057172697Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800057120254088000571202548800057120254
08800057172697088000571726978800057172697

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
08800057118268Amber® Mill MesoAmber Mill Meso C12/W4(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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976581410009Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410016Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410023Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410030Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410047Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410054Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410061Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410078Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
EDDI963011DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963051DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963061DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963071DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963081DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963091DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963161DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963171DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963431DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963441DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963451DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963821DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963831DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963841DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963851DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963861DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963941DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963951DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963961DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963971DD cubeY® HLDental Direkt GmbHEIH2026-06-02
D800FMAA01030Colour Liquid A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28