Amber® LiSi-POM

GUDID 08800057196150

Hass Corporation

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800057196150
• NIH Device Record Key: d7e1ff56-4031-42c4-957d-d1f3b1b413a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amber® LiSi-POM
• Version Model Number: Amber LiSi-POM LT R10/A3
• 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	08800057122081 [Primary]
GS1	08800057196150 [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: 2024-05-14
• Device Publish Date: 2024-05-06

On-Brand Devices [Amber® LiSi-POM]

• 08800057196655: Amber LiSi-POM LT R15/C4
• 08800057197089: Amber LiSi-POM LT R20/D4
• 08800057197072: Amber LiSi-POM LT R20/D3
• 08800057197065: Amber LiSi-POM LT R20/D2
• 08800057197058: Amber LiSi-POM LT R20/C4
• 08800057197041: Amber LiSi-POM LT R20/C3
• 08800057197034: Amber LiSi-POM LT R20/C2
• 08800057197027: Amber LiSi-POM LT R20/C1
• 08800057197010: Amber LiSi-POM LT R20/B4
• 08800057197003: Amber LiSi-POM LT R20/B3
• 08800057196990: Amber LiSi-POM LT R20/B2
• 08800057196983: Amber LiSi-POM LT R20/B1
• 08800057196976: Amber LiSi-POM LT R20/A4
• 08800057196969: Amber LiSi-POM LT R20/A3.5
• 08800057196952: Amber LiSi-POM LT R20/A3
• 08800057196945: Amber LiSi-POM LT R20/A2
• 08800057196938: Amber LiSi-POM LT R20/A1
• 08800057196921: Amber LiSi-POM LT R20/W4
• 08800057196914: Amber LiSi-POM LT R20/W3
• 08800057196907: Amber LiSi-POM LT R20/W2
• 08800057196891: Amber LiSi-POM LT R20/W1
• 08800057196884: Amber LiSi-POM HT R20/D4
• 08800057196877: Amber LiSi-POM HT R20/D3
• 08800057196860: Amber LiSi-POM HT R20/D2
• 08800057196853: Amber LiSi-POM HT R20/C4
• 08800057196846: Amber LiSi-POM HT R20/C3
• 08800057196839: Amber LiSi-POM HT R20/C2
• 08800057196822: Amber LiSi-POM HT R20/C1
• 08800057196815: Amber LiSi-POM HT R20/B4
• 08800057196808: Amber LiSi-POM HT R20/B3
• 08800057196792: Amber LiSi-POM HT R20/B2
• 08800057196785: Amber LiSi-POM HT R20/B1
• 08800057196778: Amber LiSi-POM HT R20/A4
• 08800057196761: Amber LiSi-POM HT R20/A3.5
• 08800057196754: Amber LiSi-POM HT R20/A3
• 08800057196747: Amber LiSi-POM HT R20/A2
• 08800057196730: Amber LiSi-POM HT R20/A1
• 08800057196723: Amber LiSi-POM HT R20/W4
• 08800057196716: Amber LiSi-POM HT R20/W3
• 08800057196709: Amber LiSi-POM HT R20/W2
• 08800057196693: Amber LiSi-POM HT R20/W1
• 08800057196686: Amber LiSi-POM LT R15/D4
• 08800057196679: Amber LiSi-POM LT R15/D3
• 08800057196662: Amber LiSi-POM LT R15/D2
• 08800057196648: Amber LiSi-POM LT R15/C3
• 08800057196631: Amber LiSi-POM LT R15/C2
• 08800057196624: Amber LiSi-POM LT R15/C1
• 08800057196617: Amber LiSi-POM LT R15/B4
• 08800057196600: Amber LiSi-POM LT R15/B3
• 08800057196594: Amber LiSi-POM LT R15/B2