Amber Mill Q Series & Amber Mill Direct Series
FDA 510(k)Class II (US FDA 510(k))
by Hass Corp.
Identifiers
- 510(k) Number
- K202952 FDA 510(k)
- FDA Product Code
- EIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.6660 FDA 510(k)
- Regulation Number
- 872.6660 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Amber Mill Q Series & Amber Mill Direct Series are dental implants and restorations designed for strength, stability, and aesthetic results. They are used in dental clinics by dental professionals to create restorations such as veneers. The Amber Mill Q Series features a zirconia core and a central hole for zirconia cap/abutment connection, while the Amber Mill Direct Series is a Lithium Disilicate-based millable glass ceramic block.
The devices are supplied in various forms and are used for one-block fabrication without firing, simplifying implant workflows. They offer excellent machinability, natural opalescence, and fluorescence, with multiple translucencies from one block. The Amber Mill Q Series & Amber Mill Direct Series have been authorized with FDA 510(k) clearance, with the reference code K202952.
Frequently asked questions
What are the Amber Mill Q Series and Direct Series used for?
They are used by dental professionals to create restorations such as veneers, offering strength, stability, and aesthetic results.
What materials are the Amber Mill Q Series and Direct Series made of?
The Amber Mill Q Series features a zirconia core, while the Amber Mill Direct Series is a Lithium Disilicate-based millable glass ceramic block.
Do the Amber Mill Q Series and Direct Series require firing?
No, they are designed for one-block fabrication without firing, simplifying implant workflows.
What is the regulatory status of the Amber Mill Q Series and Direct Series?
They have been authorized with FDA 510(k) clearance, with the reference code K202952.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Dental Implants with Zirconia Core | Amber Mill Q | HASS, Multiple Translucencies for Veneers | Amber Mill | HASS, Amber Mill Direct - HASSBIO America, Amber Mill Q Series & Amber Mill Direct Series (K202952) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202952 | Class II | Active |
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Manufacturer
- Manufacturer
- Hass Corp.
Sources (1)
- FDA 510(k) K202952 24 fields · synced Sep 27, 2026