FDA.reportPublic FDA data

Amber® Mill Meso

Primary DI
08800250996366
Brand
Amber® Mill Meso
Company
Hass Corporation
Model
Amber Mill Meso C16/B3(L)
Published
2025-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
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
08800057119395PrimaryGS10
08800250996366Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800057119395088000571193958800057119395
08800250996366088002509963668800250996366

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
689848555
Device count
5
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
false
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
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
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
D800FMAA05030Colour Liquid A4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA06030Colour Liquid B1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA07030Colour Liquid B2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA08030Colour Liquid B3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA09030Colour Liquid B4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA10030Colour Liquid C1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA11030Colour Liquid C2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA12030Colour Liquid C3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28