Amber® Press

GUDID 08800057172260

Hass Corporation

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800057172260
• NIH Device Record Key: 32402daa-4b34-45bc-aaec-a16ff084f3ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amber® Press
• Version Model Number: Amber Press HT R20/B4
• Company DUNS: 689848555
• Company Name: Hass Corporation
• Device Count: 3
• 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	08800057112501 [Primary]
GS1	08800057172260 [Unit of Use]

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® Press]

• 08800057172222: Amber Press HT R20/A4
• 08800057172017: Amber Press LT R20/A4
• 08800057171751: Amber Press HT R15/A4
• 08800057171546: Amber Press LT R15/A4
• 08800057171287: Amber Press HT R10/A4
• 08800057171072: Amber Press LT R10/A4
• 08800057170976: Amber Press MO R7/4
• 08800057170969: Amber Press MO R7/3
• 08800057170952: Amber Press MO R7/2
• 08800057170945: Amber Press MO R7/1
• 08800057170938: Amber Press MO R7/0
• 08800057170921: Amber Press HT R7/D4
• 08800057170914: Amber Press HT R7/D3
• 08800057170907: Amber Press HT R7/D2
• 08800057170891: Amber Press HT R7/C4
• 08800057170884: Amber Press HT R7/C3
• 08800057170877: Amber Press HT R7/C2
• 08800057170860: Amber Press HT R7/C1
• 08800057170853: Amber Press HT R7/B4
• 08800057170846: Amber Press HT R7/B3
• 08800057170839: Amber Press HT R7/B2
• 08800057170822: Amber Press HT R7/B1
• 08800057170815: Amber Press HT R7/A4
• 08800057170808: Amber Press HT R7/A3.5
• 08800057170792: Amber Press HT R7/A3
• 08800057170785: Amber Press HT R7/A2
• 08800057170778: Amber Press HT R7/A1
• 08800057170761: Amber Press HT R7/W4
• 08800057170754: Amber Press HT R7/W3
• 08800057170747: Amber Press HT R7/W2
• 08800057170730: Amber Press HT R7/W1
• 08800057170716: Amber Press LT R7/D4
• 08800057170709: Amber Press LT R7/D3
• 08800057170693: Amber Press LT R7/D2
• 08800057170686: Amber Press LT R7/C4
• 08800057170679: Amber Press LT R7/C3
• 08800057170662: Amber Press LT R7/C2
• 08800057170655: Amber Press LT R7/C1
• 08800057170648: Amber Press LT R7/B4
• 08800057170631: Amber Press LT R7/B3
• 08800057170624: Amber Press LT R7/B2
• 08800057170617: Amber Press LT R7/B1
• 08800057170600: Amber Press LT R7/A4
• 08800057170594: Amber Press LT R7/A3.5
• 08800057170587: Amber Press LT R7/A3
• 08800057170570: Amber Press LT R7/A2
• 08800057170563: Amber Press LT R7/A1
• 08800057170556: Amber Press LT R7/W4
• 08800057170549: Amber Press LT R7/W3
• 08800057170532: Amber Press LT R7/W2