Identity
- Trade Name
- Amber® Mill Direct FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Model / Reference
- Amber Mill Direct HT+ C12/W1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800057136651 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
Introducing the Amber Mill Direct, a high-performance dental appliance fabrication material made from ceramic materials. This advanced material is designed to provide optimal strength, durability, and aesthetics for patient use. With its unique composition and manufacturing process, the Amber Mill Direct offers unparalleled capabilities in dental prosthesis creation.
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hass Corporation
Sources (1)
- FDA UDI 2e2c92a0-3256-4797-97c3-aeafbea23665 33 fields · synced Jul 30, 2026