Amber® LiSi-POZ

GUDID 08800057173915

Hass Corporation

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800057173915
• NIH Device Record Key: f0fd8133-8531-4e19-8cba-710323b4121c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amber® LiSi-POZ
• Version Model Number: Amber LiSi-POZ LT R15/C3
• 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	08800057113201 [Primary]
GS1	08800057173915 [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-POZ]

• 08800057175056: Amber LiSi-POZ MT R20/D4
• 08800057175049: Amber LiSi-POZ MT R20/D3
• 08800057175032: Amber LiSi-POZ MT R20/D2
• 08800057175025: Amber LiSi-POZ MT R20/C4
• 08800057175018: Amber LiSi-POZ MT R20/C3
• 08800057175001: Amber LiSi-POZ MT R20/C2
• 08800057174998: Amber LiSi-POZ MT R20/C1
• 08800057174981: Amber LiSi-POZ MT R20/B4
• 08800057174974: Amber LiSi-POZ MT R20/B3
• 08800057174967: Amber LiSi-POZ MT R20/B2
• 08800057174950: Amber LiSi-POZ MT R20/B1
• 08800057174943: Amber LiSi-POZ MT R20/A4
• 08800057174936: Amber LiSi-POZ MT R20/A3.5
• 08800057174929: Amber LiSi-POZ MT R20/A3
• 08800057174233: Amber LiSi-POZ MT R20/A2
• 08800057174905: Amber LiSi-POZ MT R20/A1
• 08800057174899: Amber LiSi-POZ MT R20/W4
• 08800057174882: Amber LiSi-POZ MT R20/W3
• 08800057174875: Amber LiSi-POZ MT R20/W2
• 08800057174868: Amber LiSi-POZ MT R20/W1
• 08800057174851: Amber LiSi-POZ MT R20/W0
• 08800057174738: Amber LiSi-POZ HT R20/A4
• 08800057174646: Amber LiSi-POZ HT R20/W0
• 08800057174523: Amber LiSi-POZ LT R20/A4
• 08800057174431: Amber LiSi-POZ LT R20/W0
• 08800057174370: Amber LiSi-POZ MT R15/D4
• 08800057174363: Amber LiSi-POZ MT R15/D3
• 08800057174356: Amber LiSi-POZ MT R15/D2
• 08800057174349: Amber LiSi-POZ MT R15/C4
• 08800057174332: Amber LiSi-POZ MT R15/C3
• 08800057174325: Amber LiSi-POZ MT R15/C2
• 08800057174318: Amber LiSi-POZ MT R15/C1
• 08800057174301: Amber LiSi-POZ MT R15/B4
• 08800057174295: Amber LiSi-POZ MT R15/B3
• 08800057174288: Amber LiSi-POZ MT R15/B2
• 08800057174271: Amber LiSi-POZ MT R15/B1
• 08800057174264: Amber LiSi-POZ MT R15/A4
• 08800057174257: Amber LiSi-POZ MT R15/A3.5
• 08800057174240: Amber LiSi-POZ MT R15/A3
• 08800057174912: Amber LiSi-POZ MT R20/A2
• 08800057174226: Amber LiSi-POZ MT R15/A1
• 08800057174219: Amber LiSi-POZ MT R15/W4
• 08800057174202: Amber LiSi-POZ MT R15/W3
• 08800057174196: Amber LiSi-POZ MT R15/W2
• 08800057174189: Amber LiSi-POZ MT R15/W1
• 08800057174172: Amber LiSi-POZ MT R15/W0
• 08800057174059: Amber LiSi-POZ HT R15/A4
• 08800057173960: Amber LiSi-POZ HT R15/W0
• 08800057173847: Amber LiSi-POZ LT R15/A4
• 08800057173755: Amber LiSi-POZ LT R15/W0