Obsidian® Press Over Zirconia— 510(k) K262239
Substantially EquivalentPrismatik Dentalcraft, Inc.
FDA 510(k) clearance K262239 for Obsidian® Press Over Zirconia, Substantially Equivalent on 2026-07-30. Applicant: Prismatik Dentalcraft, Inc.. Device class: 2.
Summary
Prismatik Dentalcraft's Obsidian Press Over Zirconia is filed under EIH, porcelain powder. The name refers to zirconia, which the code name doesn't mention, and the record gives no composition.
Class II, 21 CFR 872.6660. Dental is both the classification panel and the review panel. It came in as a Special 510(k).
Prismatik Dentalcraft filed from Irvine, California. The decision came 29 calendar days after FDA received it (July 1 to July 30, 2026).
Clearance details
- Applicant
- Prismatik Dentalcraft, Inc.
- Product code
- Product code EIH
- Device class
- Class 2
- Regulation
- 21 CFR 872.6660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
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