BRUXZIR SHADED— 510(k) K130924

Substantially Equivalent

Prismatik Dentalcraft, Inc.

FDA 510(k) clearance K130924 for BRUXZIR SHADED, Substantially Equivalent on 2013-05-16. Applicant: Prismatik Dentalcraft, Inc.. Device class: 2.

Clearance details

Applicant: Prismatik Dentalcraft, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2013-04-03
Decision date: 2013-05-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

K262074 — Any-Zircos2026-08-21
K262239 — Obsidian® Press Over Zirconia2026-07-30
K261046 — Dental Zirconia Blank & Coloring Liquid2026-07-17
K262195 — Dandy Ceramic Stain and Glaze2026-06-30
K260918 — Zolid Lunaris2026-06-29

More clearances from Prismatik Dentalcraft, Inc.

K261802 — Glidewell Denture Base Resin2026-08-27
K254283 — BruxZir® Shaded 16 PLUS2026-01-30
K252582 — Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems2025-11-18
K252446 — BruxZir® NOW2025-09-03
K250302 — Flexible Partial Resin2025-06-25

Recalls naming K130924

K-number listed on FDA's recall record

Z-2897-2016 — BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.Class II·Terminated·Prismatik Dentalcraft, Inc·20160815

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130924.

Data sourced from openFDA. This site is unofficial and independent of the FDA.