Amber® Mill Direct

GUDID 08800057178309

Hass Corporation

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800057178309
• NIH Device Record Key: c3a31a07-0ee3-453a-a830-ddcac4a420ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amber® Mill Direct
• Version Model Number: Amber Mill Direct HT C12/D3
• Company DUNS: 689848555
• Company Name: Hass Corporation
• Device Count: 5
• 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	08800057137283 [Primary]
GS1	08800057178309 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202952

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: 2024-05-14
• Device Publish Date: 2024-05-06

On-Brand Devices [Amber® Mill Direct]

• 08800057179214: Amber Mill Direct MT C16/W0
• 08800057179009: Amber Mill Direct HT C16/W0
• 08800057178798: Amber Mill Direct HT+ C16/W0
• 08800057178583: Amber Mill Direct LT C16/W0
• 08800057178323: Amber Mill Direct MT C12/W0
• 08800057178118: Amber Mill Direct HT C12/W0
• 08800057177906: Amber Mill Direct HT+ C12/W0
• 08800057177692: Amber Mill Direct LT C12/W0
• 08800057177432: Amber Mill Direct MT C14/W0
• 08800057177227: Amber Mill Direct HT C14/W0
• 08800057177012: Amber Mill Direct HT+ C14/W0
• 08800057176800: Amber Mill Direct LT C14/W0
• 08800057178996: Amber Mill Direct HT+ C16/D4
• 08800057178989: Amber Mill Direct HT+ C16/D3
• 08800057178972: Amber Mill Direct HT+ C16/D2
• 08800057178965: Amber Mill Direct HT+ C16/C4
• 08800057178958: Amber Mill Direct HT+ C16/C3
• 08800057178941: Amber Mill Direct HT+ C16/C2
• 08800057178934: Amber Mill Direct HT+ C16/C1
• 08800057178927: Amber Mill Direct HT+ C16/B4
• 08800057178910: Amber Mill Direct HT+ C16/B3
• 08800057178903: Amber Mill Direct HT+ C16/B2
• 08800057178897: Amber Mill Direct HT+ C16/B1
• 08800057178880: Amber Mill Direct HT+ C16/A4
• 08800057178873: Amber Mill Direct HT+ C16/A3.5
• 08800057178866: Amber Mill Direct HT+ C16/A3
• 08800057178859: Amber Mill Direct HT+ C16/A2
• 08800057178842: Amber Mill Direct HT+ C16/A1
• 08800057178835: Amber Mill Direct HT+ C16/W4
• 08800057178828: Amber Mill Direct HT+ C16/W3
• 08800057178811: Amber Mill Direct HT+ C16/W2
• 08800057178804: Amber Mill Direct HT+ C16/W1
• 08800057177210: Amber Mill Direct HT+ C14/D4
• 08800057177203: Amber Mill Direct HT+ C14/D3
• 08800057177197: Amber Mill Direct HT+ C14/D2
• 08800057177180: Amber Mill Direct HT+ C14/C4
• 08800057177173: Amber Mill Direct HT+ C14/C3
• 08800057177166: Amber Mill Direct HT+ C14/C2
• 08800057177159: Amber Mill Direct HT+ C14/C1
• 08800057177142: Amber Mill Direct HT+ C14/B4
• 08800057177135: Amber Mill Direct HT+ C14/B3
• 08800057177128: Amber Mill Direct HT+ C14/B2
• 08800057177111: Amber Mill Direct HT+ C14/B1
• 08800057177104: Amber Mill Direct HT+ C14/A4
• 08800057177098: Amber Mill Direct HT+ C14/A3.5
• 08800057177081: Amber Mill Direct HT+ C14/A3
• 08800057177074: Amber Mill Direct HT+ C14/A2
• 08800057177067: Amber Mill Direct HT+ C14/A1
• 08800057177050: Amber Mill Direct HT+ C14/W4
• 08800057177043: Amber Mill Direct HT+ C14/W3