FDA.reportPublic FDA data

Amber® Mill Q

Primary DI
08800057186335
Brand
Amber® Mill Q
Company
Hass Corporation
Model
Amber Mill Q MT C12/W0 TB3.0S
Published
2024-05-06
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
K202952000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202952000Amber Mill Q Series & Amber Mill Direct SeriesHass Corp.2021-08-26EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800057169963PrimaryGS10
08800057170105PrimaryGS10
08800057186335Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800057169963088000571699638800057169963
08800057170105088000571701058800057170105
08800057186335088000571863358800057186335

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

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Primary DI, Brand, Company table
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