IPS e.max One
FDA 510(k) K211916 · Ivoclar Vivadent, AG
510(k) numberK211916
Submission
- Device name
- IPS e.max One
- Applicant
- Ivoclar Vivadent, AG
Schaan, LI - Received
- June 21, 2021
- Decision date
- August 20, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K262074 | Any-ZircosEIH · Traditional | Mediclus Co., Ltd. | 08/21/2026SE |
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| 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 |
|---|---|---|
| K261485 | Tetric plus Fill;Tetric plus FlowEBF · Traditional | 07/01/2026SE |
| K253953 | IPS e.max ZirconiaEIH · Traditional | 03/10/2026SE |
| K252450 | Adhese 2KLE · Traditional | 03/05/2026SE |
| K233995 | Ivotion Base PrintEBI · Traditional | 02/23/2024SE |
| K210804 | Adhese Universal DC, Cention PrimerKLE · Traditional | 06/07/2022SE |
| K193193 | Telio CAD Abutment Solutions- extra systemsNHA · Abbreviated | 11/16/2020SE |
| K191453 | Cervitec FLBH · Traditional | 02/11/2020SE |
| K191448 | Barrier SleevesPEM · Traditional | 10/08/2019SE |
| K191382 | IPS e.max CAD Abutment Solutions- extra systemsNHA · Abbreviated | 08/26/2019SE |
| K190339 | Helioseal F PlusEBC · Abbreviated | 07/29/2019SE |
Questions and answers
When was IPS e.max One cleared by the FDA?
IPS e.max One (K211916) received a 510(k) decision of Substantially Equivalent on August 20, 2021, 60 days after the submission was received.
What is the product code of K211916?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.