Amber® Press Master

GUDID 08800057176282

Hass Corporation

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800057176282
• NIH Device Record Key: 6807d68a-4a3d-4b8d-8602-c3c38f7bb1c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amber® Press Master
• Version Model Number: Amber Press Master HT+ R10/W2
• 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	08800057158493 [Primary]
GS1	08800057176282 [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 Master]

• 08800057176343: Amber Press Master HT+ R10/A2
• 08800057176329: Amber Press Master HT+ R10/A1
• 08800057176305: Amber Press Master HT+ R10/W4
• 08800057176299: Amber Press Master HT+ R10/W3
• 08800057176282: Amber Press Master HT+ R10/W2
• 08800057176268: Amber Press Master MT R10/D2
• 08800057176237: Amber Press Master MT R10/B1
• 08800057176213: Amber Press Master MT R10/A2
• 08800057176190: Amber Press Master MT R10/A1
• 08800057176176: Amber Press Master MT R10/W4
• 08800057176336: Amber Press Master HT+ R10/A1.5
• 08800057176312: Amber Press Master HT+ R10/A0.5
• 08800057176275: Amber Press Master HT+ R10/W0.5
• 08800057176220: Amber Press Master MT R10/A2.5
• 08800057176206: Amber Press Master MT R10/A1.5
• 08800057176183: Amber Press Master MT R10/A0.5
• 08800057176169: Amber Press Master MT R10/W0.5
• 08800057176794: Amber Press Master HT R20/B2
• 08800057176787: Amber Press Master HT R20/B1
• 08800057176770: Amber Press Master HT R20/A3
• 08800057176763: Amber Press Master HT R20/A2
• 08800057176756: Amber Press Master HT R20/A1
• 08800057176749: Amber Press Master HT R20/W4
• 08800057176688: Amber Press Master HT+ R20/A3
• 08800057176664: Amber Press Master HT+ R20/A2
• 08800057176640: Amber Press Master HT+ R20/A1
• 08800057176626: Amber Press Master HT+ R20/W4
• 08800057176619: Amber Press Master HT+ R20/W3
• 08800057176602: Amber Press Master HT+ R20/W2
• 08800057176589: Amber Press Master MT R20/D2
• 08800057176572: Amber Press Master MT R20/C2
• 08800057176565: Amber Press Master MT R20/B2
• 08800057176558: Amber Press Master MT R20/B1
• 08800057176534: Amber Press Master MT R20/A2
• 08800057176510: Amber Press Master MT R20/A1
• 08800057176497: Amber Press Master MT R20/W4
• 08800057176473: Amber Press Master HT R10/B2
• 08800057176466: Amber Press Master HT R10/B1
• 08800057176459: Amber Press Master HT R10/A3
• 08800057176442: Amber Press Master HT R10/A2
• 08800057176435: Amber Press Master HT R10/A1
• 08800057176428: Amber Press Master HT R10/W4
• 08800057176367: Amber Press Master HT+ R10/A3
• 08800057176251: Amber Press Master MT R10/C2
• 08800057176244: Amber Press Master MT R10/B2
• 08800057176732: Amber Press Master LO R20/3
• 08800057176725: Amber Press Master LO R20/2
• 08800057176718: Amber Press Master LO R20/1
• 08800057176701: Amber Press Master LO R20/0
• 08800057176695: Amber Press Master HT+ R20/A3.5