Noritake Super Porcelain EX-3
FDA 510(k) K193060 · Kuraray Noritake Dental, Inc.
510(k) numberK193060
Submission
- Device name
- Noritake Super Porcelain EX-3
- Applicant
- Kuraray Noritake Dental, Inc.
Chiyoda-Ku, JP - Received
- November 1, 2019
- Decision date
- January 30, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K250673 | CERABIEN MiLaiEIH · Traditional | 05/29/2025SE |
| K233285 | KATANA Zirconia ONE For IMPLANTNHA · Traditional | 05/24/2024SE |
| K231039 | CLEARFIL Universal Bond Quick 2KLE · Traditional | 12/13/2023SE |
| K220369 | Esthetic ColorantEIH · Traditional | 09/23/2022SE |
| K213147 | CERABIEN MiLaiEIH · Traditional | 03/28/2022SE |
| K210504 | PANAVIA Veneer LCEMA · Traditional | 06/11/2021SE |
| K191980 | CLEARFIL MAJESTY ES FlowEBF · Traditional | 11/18/2019SE |
| K191133 | KATANA Cleaner, KATANA Cleaner (Trial)PME · Traditional | 10/08/2019SE |
| K190436 | KATANA Zirconia BlockEIH · Traditional | 05/23/2019SE |
| K182430 | Clearfil Majesty IcEBF · Traditional | 05/03/2019SE |
Questions and answers
When was Noritake Super Porcelain EX-3 cleared by the FDA?
Noritake Super Porcelain EX-3 (K193060) received a 510(k) decision of Substantially Equivalent on January 30, 2020, 90 days after the submission was received.
What is the product code of K193060?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.