FDA.reportPublic FDA data

Amber® Mill Meso

Primary DI
08800057118275
Brand
Amber® Mill Meso
Company
Hass Corporation
Model
Amber Mill Meso C12/A1(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
08800057118275PrimaryGS10
08800250995246Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800057118275088000571182758800057118275
08800250995246088002509952468800250995246

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
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

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Primary DI, Brand, Company table
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EYET388000010K2 MyStains Structure SetYeti Dentalprodukte GmbHEIH2026-05-20
EYET38800230K2 MyStains ST-S13, uni red, 2g.Yeti Dentalprodukte GmbHEIH2026-05-20
EYET38800240K2 MyStains ST-S14, uni gingiva, 2g.Yeti Dentalprodukte GmbHEIH2026-05-20
EYET38780110K2 Li-Press-Pellets (HT-Hoch Transluzent) B1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780120K2 Li-Press-Pellets (HT-Hoch Transluzent) B1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780210K2 Li-Press-Pellets (HT-Hoch Transluzent) C1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780310K2 Li-Press-Pellets (HT-Hoch Transluzent) BL1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780320K2 Li-Press-Pellets (HT-Hoch Transluzent) BL3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780330K2 Li-Press-Pellets (HT-Hoch Transluzent) BL2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780340K2 Li-Press-Pellets (HT-Hoch Transluzent) BL4, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781010K2 Li-Press-Pellets (LT-Low Transluzent) A1, 5X3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781020K2 Li-Press-Pellets (LT-Low Transluzent) A2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781030K2 Li-Press-Pellets (LT-Low Transluzent) A3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781110K2 Li-Press-Pellets (LT-Low Transluzent) B1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781120K2 Li-Press-Pellets (LT-Low Transluzent) B2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781210K2 Li-Press-Pellets (LT-Low Transluzent) C1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781310K2 Li-Press-Pellets (LT-Low Transluzent) BL1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781320K2 Li-Press-Pellets (LT-Low Transluzent) BL2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781330K2 Li-Press-Pellets (LT-Low Transluzent) BL3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781340K2 Li-Press-Pellets (LT-Low Transluzent) BL4, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38782010K2 Li-Press-Pellets (medium-opak) MO1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780010K2 Li Press-Pellets HT-A1Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38780020K2 Li Press-Pellets HT-A2Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38780030K2 Li-Press-Pellets (HT-Hoch Transluzent) A3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38801100K2 MyStains Structure Body dark, SM-B-D, 2g.Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38760020K2 Li-Mamelon, MM-HO (HONEY), 20g.Yeti Dentalprodukte GmbHEIH2026-05-05
EYET38626150K2-HF OPAQUE DENTIN, OD-D3, 50g.Yeti Dentalprodukte GmbHEIH2026-05-04
EYET38750060K2 Li-Clear, CL, 20g.Yeti Dentalprodukte GmbHEIH2026-05-04
EYET38760010K2 Li-Mamelon, MM-OR (ORANGE), 20g.Yeti Dentalprodukte GmbHEIH2026-05-04