Amber® Mill

GUDID 08800057115090

Hass Corporation

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800057115090
• NIH Device Record Key: 249c759d-3ac7-47c6-a5ab-18ea632cb08e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amber® Mill
• Version Model Number: Amber MIll P9808/W4
• Company DUNS: 689848555
• Company Name: Hass Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800057115090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160102

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-09
• Device Publish Date: 2024-05-01

On-Brand Devices [Amber® Mill]

• 08800057169666: Amber MIll Z9520/A4
• 08800057169659: Amber MIll Z9520/W0
• 08800057169642: Amber MIll Z9518/A4
• 08800057169635: Amber MIll Z9518/W0
• 08800057169628: Amber MIll Z9516/A4
• 08800057169611: Amber MIll Z9516/W0
• 08800057169604: Amber MIll Z9514/A4
• 08800057169598: Amber MIll Z9514/W0
• 08800057169581: Amber MIll Z9512/A4
• 08800057169574: Amber MIll Z9512/W0
• 08800057169567: Amber MIll Z9510/A4
• 08800057169550: Amber MIll Z9510/W0
• 08800057169543: Amber MIll P9820/A4
• 08800057169536: Amber MIll P9820/W0
• 08800057169529: Amber MIll P9818/A4
• 08800057169512: Amber MIll P9818/W0
• 08800057169505: Amber MIll P9816/A4
• 08800057169499: Amber MIll P9816/W0
• 08800057169482: Amber MIll P9814/A4
• 08800057169475: Amber MIll P9814/W0
• 08800057169468: Amber MIll P9812/A4
• 08800057169451: Amber MIll P9812/W0
• 08800057169444: Amber MIll P9810/A4
• 08800057169437: Amber MIll P9810/W0
• 08800057169420: Amber MIll P9808/A4
• 08800057169413: Amber MIll P9808/W0
• 08800057169406: Amber MIll P9806/A4
• 08800057169390: Amber MIll P9806/W0
• 08800057162322: Amber MIll H9816/W0
• 08800057162315: Amber MIll H9814/W0
• 08800057162308: Amber MIll H9812/W0
• 08800057162292: Amber MIll H9810/W0
• 08800057162285: Amber MIll H9808/W0
• 08800057176046: Amber MIll C40/A4
• 08800057175957: Amber MIll C40/W0
• 08800057175834: Amber MIll C32/A4
• 08800057175742: Amber MIll C32/W0
• 08800057175735: Amber MIll C16/D4
• 08800057175728: Amber MIll C16/D3
• 08800057175711: Amber MIll C16/D2
• 08800057175704: Amber MIll C16/C4
• 08800057175698: Amber MIll C16/C3
• 08800057175681: Amber MIll C16/C2
• 08800057175674: Amber MIll C16/C1
• 08800057175667: Amber MIll C16/B4
• 08800057175650: Amber MIll C16/B3
• 08800057175643: Amber MIll C16/B2
• 08800057175636: Amber MIll C16/B1
• 08800057175629: Amber MIll C16/A4
• 08800057175612: Amber MIll C16/A3.5