Obsidian® Press Over Zirconia
FDA 510(k) K262239 · Prismatik Dentalcraft, Inc.
510(k) numberK262239
Submission
- Device name
- Obsidian® Press Over Zirconia
- Applicant
- Prismatik Dentalcraft, Inc.
Irvine, CA, US - Received
- July 1, 2026
- Decision date
- July 30, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K254283 | BruxZir® Shaded 16 PLUSEIH · Special | Prismatik Dentalcraft, Inc. | 01/30/2026SE |
More from Prismatik Dentalcraft, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261802 | Glidewell Denture Base ResinEBI · Traditional | 08/27/2026SE |
| K254283 | BruxZir® Shaded 16 PLUSEIH · Special | 01/30/2026SE |
| K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…NHA · Traditional | 11/18/2025SE |
| K252446 | BruxZir® NOWEIH · Special | 09/03/2025SE |
| K250302 | Flexible Partial ResinEBI · Traditional | 06/25/2025SE |
| K242564 | Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant…KCT · Traditional | 03/21/2025SE |
| K250223 | BruxZir® Esthetic NOWEIH · Special | 02/25/2025SE |
| K241493 | Glidewell 3DP Denture Base ResinEBI · Traditional | 09/12/2024SE |
| K240240 | Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…NHA · Traditional | 07/12/2024SE |
| K231940 | BruxZir® NOW SRCNHA · Traditional | 05/15/2024SE |
Questions and answers
When was Obsidian® Press Over Zirconia cleared by the FDA?
Obsidian® Press Over Zirconia (K262239) received a 510(k) decision of Substantially Equivalent on July 30, 2026, 29 days after the submission was received.
What is the product code of K262239?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.