Amber Mill Q Series & Amber Mill Direct Series
FDA 510(k) K202952 · Hass Corp.
510(k) numberK202952
Submission
- Device name
- Amber Mill Q Series & Amber Mill Direct Series
- Applicant
- Hass Corp.
Gangneung-Si, KR - Received
- September 30, 2020
- Decision date
- August 26, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262074 | Any-ZircosEIH · Traditional | Mediclus Co., Ltd. | 08/21/2026SE |
| K262239 | Obsidian® Press Over ZirconiaEIH · Special | Prismatik Dentalcraft, Inc. | 07/30/2026SE |
| K261046 | Dental Zirconia Blank & Coloring LiquidEIH · Traditional | Hunan Qinghao Puzhong Technology Co., Ltd. | 07/17/2026SE |
| K262195 | Dandy Ceramic Stain and GlazeEIH · Traditional | Zima International Inc., dba Dandy | 06/30/2026SE |
| K260918 | Zolid LunarisEIH · Traditional | Amann Girrbach AG | 06/29/2026SE |
| K260859 | Rosetta SM, Rosetta SPEIH · Traditional | Hass Corp. | 06/11/2026SE |
| K253191 | DCMhotbond zirconEIH · Traditional | Dental Creativ Management GmbH | 05/21/2026SE |
| K260067 | Eternal Art Porcelain PowdersEIH · Traditional | Shandong Huge Dental Material Corporation | 04/09/2026SE |
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankEIH · Traditional | Bloomden Bioceramics (HuNan) Co., Ltd. | 03/30/2026SE |
| K253953 | IPS e.max ZirconiaEIH · Traditional | Ivoclar Vivadent, Inc. | 03/10/2026SE |
More from Ivoclar Vivadent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260859 | Rosetta SM, Rosetta SPEIH · Traditional | 06/11/2026SE |
| K160102 | Amber Mill Series and Amber Press SeriesEIH · Traditional | 07/14/2016SE |
| K111573 | Monobloc BM SeriesEIH · Traditional | 08/26/2011SE |
| K102305 | Hass Zirtooth Model Zortooth H. Zirtooth T. Zirtoothc, Zirtooth PEIH · Traditional | 12/03/2010SE |
Questions and answers
When was Amber Mill Q Series & Amber Mill Direct Series cleared by the FDA?
Amber Mill Q Series & Amber Mill Direct Series (K202952) received a 510(k) decision of Substantially Equivalent on August 26, 2021, 330 days after the submission was received.
What is the product code of K202952?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.