Amber® Mill Q

GUDID 08800057184416

Hass Corporation

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800057184416
• NIH Device Record Key: 56380a7c-6c95-42ec-ad7b-db22b0ccf8da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amber® Mill Q
• Version Model Number: Amber Mill Q HT C12/A3 TB5.4L
• 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	08800057142157 [Primary]
GS1	08800057145400 [Primary]
GS1	08800057184416 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160102
• 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 Q]

• 08800057195238: Amber Mill Q MT C16/W0 (L)
• 08800057195023: Amber Mill Q HT C16/W0 (L)
• 08800057194811: Amber Mill Q HT+ C16/W0 (L)
• 08800057194606: Amber Mill Q LT C16/W0 (L)
• 08800057194347: Amber Mill Q MT C12/W0 (L)
• 08800057194132: Amber Mill Q HT C12/W0 (L)
• 08800057193920: Amber Mill Q HT+ C12/W0 (L)
• 08800057193715: Amber Mill Q LT C12/W0 (L)
• 08800057193456: Amber Mill Q MT C14/W0 (L)
• 08800057193241: Amber Mill Q HT C14/W0 (L)
• 08800057193036: Amber Mill Q HT+ C14/W0 (L)
• 08800057192824: Amber Mill Q LT C14/W0 (L)
• 08800057192565: Amber Mill Q MT C16/W0 TB4.8L
• 08800057192350: Amber Mill Q HT C16/W0 TB4.8L
• 08800057192145: Amber Mill Q HT+ C16/W0 TB4.8L
• 08800057191933: Amber Mill Q LT C16/W0 TB4.8L
• 08800057191674: Amber Mill Q MT C16/W0 TB3.5L
• 08800057191469: Amber Mill Q HT C16/W0 TB3.5L
• 08800057191254: Amber Mill Q HT+ C16/W0 TB3.5L
• 08800057191049: Amber Mill Q LT C16/W0 TB3.5L
• 08800057190783: Amber Mill Q MT C16/W0 TB3.0S
• 08800057190578: Amber Mill Q HT C16/W0 TB3.0S
• 08800057190363: Amber Mill Q HT+ C16/W0 TB3.0S
• 08800057190158: Amber Mill Q LT C16/W0 TB3.0S
• 08800057189893: Amber Mill Q MT C16/W0 TB4.1L
• 08800057189688: Amber Mill Q HT C16/W0 TB4.1L
• 08800057189473: Amber Mill Q HT+ C16/W0 TB4.1L
• 08800057189268: Amber Mill Q LT C16/W0 TB4.1L
• 08800057189008: Amber Mill Q MT C16/W0 TB5.4L
• 08800057188797: Amber Mill Q HT C16/W0 TB5.4L
• 08800057188582: Amber Mill Q HT+ C16/W0 TB5.4L
• 08800057188377: Amber Mill Q LT C16/W0 TB5.4L
• 08800057188117: Amber Mill Q MT C12/W0 TB4.8L
• 08800057187905: Amber Mill Q HT C12/W0 TB4.8L
• 08800057187691: Amber Mill Q HT+ C12/W0 TB4.8L
• 08800057187486: Amber Mill Q LT C12/W0 TB4.8L
• 08800057187226: Amber Mill Q MT C12/W0 TB3.5L
• 08800057187011: Amber Mill Q HT C12/W0 TB3.5L
• 08800057186809: Amber Mill Q HT+ C12/W0 TB3.5L
• 08800057186595: Amber Mill Q LT C12/W0 TB3.5L
• 08800057186335: Amber Mill Q MT C12/W0 TB3.0S
• 08800057186120: Amber Mill Q HT C12/W0 TB3.0S
• 08800057185918: Amber Mill Q HT+ C12/W0 TB3.0S
• 08800057185703: Amber Mill Q LT C12/W0 TB3.0S
• 08800057185444: Amber Mill Q MT C12/W0 TB4.1L
• 08800057185239: Amber Mill Q HT C12/W0 TB4.1L
• 08800057185024: Amber Mill Q HT+ C12/W0 TB4.1L
• 08800057184812: Amber Mill Q LT C12/W0 TB4.1L
• 08800057184553: Amber Mill Q MT C12/W0 TB5.4L
• 08800057184348: Amber Mill Q HT C12/W0 TB5.4L