BruxZir® Shaded 16 PLUS
FDA 510(k) K254283 · Prismatik Dentalcraft, Inc.
510(k) numberK254283
Submission
- Device name
- BruxZir® Shaded 16 PLUS
- Applicant
- Prismatik Dentalcraft, Inc.
Irvine, CA, US - Received
- December 31, 2025
- Decision date
- January 30, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| 510(k) | Device | Decision |
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| K261802 | Glidewell Denture Base ResinEBI · Traditional | 08/27/2026SE |
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| 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 BruxZir® Shaded 16 PLUS cleared by the FDA?
BruxZir® Shaded 16 PLUS (K254283) received a 510(k) decision of Substantially Equivalent on January 30, 2026, 30 days after the submission was received.
What is the product code of K254283?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.