Identity
- Trade Name
- Amber® Mill Q FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Model / Reference
- Amber Mill Q LT C12/B1 (L) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800057166672 FDA UDI
- 510(k) Number
- K202952 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental appliance fabrication material, ceramic
Amber Mill Q is a high-quality dental appliance fabrication material made from ceramic materials (e.g., zirconium oxide) suitable for creating implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. This material has been proven to be safe in MRI scans, making it an ideal choice for dental applications.
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Cleared under the same submission
K202952 also covers:
- Amber® Mill Direct — Hass Corporation
- Amber® Mill Direct — Hass Corporation
- Amber® Mill Direct — Hass Corporation
- Amber® Mill Direct — Hass Corporation
- Amber® Mill Direct — Hass Corporation
- Amber® Mill Direct — Hass Corporation
- Amber® Mill Q — Hass Corporation
- Amber® Mill Q — Hass Corporation
- Amber® Mill Q — Hass Corporation
- Amber® Mill Q — Hass Corporation
- Amber® Mill Q — Hass Corporation
- Amber® Mill Q — Hass Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hass Corporation
Sources (1)
- FDA UDI 48db219e-22cc-4a42-bba1-06125399266b 33 fields · synced Oct 6, 2026