Rosetta SM, Rosetta SP
FDA 510(k) K260859 · Hass Corp.
510(k) numberK260859
Submission
- Device name
- Rosetta SM, Rosetta SP
- Applicant
- Hass Corp.
Gangneung-Si, KR - Received
- March 16, 2026
- Decision date
- June 11, 2026
- 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 |
| 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 |
| K254283 | BruxZir® Shaded 16 PLUSEIH · Special | Prismatik Dentalcraft, Inc. | 01/30/2026SE |
More from Prismatik Dentalcraft, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K202952 | Amber Mill Q Series & Amber Mill Direct SeriesEIH · Traditional | 08/26/2021SE |
| 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 Rosetta SM, Rosetta SP cleared by the FDA?
Rosetta SM, Rosetta SP (K260859) received a 510(k) decision of Substantially Equivalent on June 11, 2026, 87 days after the submission was received.
What is the product code of K260859?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.