510(k) · Cleared

Cleared

BruxZir® Shaded 16 PLUS

K254283510(k) SpecialCleared Jan 30, 202630-day reviewClass II21 CFR 872.6660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Prismatik Dentalcraft, Inc. · EIH Powder, Porcelain

Cleared on Jan 30, 2026 as substantially equivalent to K130924 (Prismatik Dentalcraft, Inc., 2013) after a 30-day review. Its family tree reaches back 2 generations to 2006.

Decided: Jan 30, 2026
Review: 30 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K060104 (2006). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK060104 Prismatik Clinical ZirconiaGlidewell Laboratories · 2006
1 generation backK130924 Bruxzir ShadedPrismatik Dentalcraft, Inc. · 2013 · Recalled
This deviceK254283 BruxZir® Shaded 16 PLUSPrismatik Dentalcraft, Inc. · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K060104	Prismatik Clinical Zirconia	Glidewell Laboratories	2006	—
−1	K130924	Bruxzir Shaded	Prismatik Dentalcraft, Inc.	2013	1
0 (this device)	K254283	BruxZir® Shaded 16 PLUS	Prismatik Dentalcraft, Inc.	2026	—

FIG. 1 — Lineage of K254283, 2006–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new EIH device

#1 K192231 Dental Glass Ceramics Blocksscore 15.2 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K130924	Bruxzir Shaded Summary page 5 …er for clinical use Regulation Number: 872.6660 Regulatory Class: Class II Product Code: EIH LEGALLY MARKETED PREDICATE DEVICE (21 CFR 807.92(a)(3)) Predicate 510(k) #: K130924 Predicate Device Trade Name: BruxZir® Shaded Product Code: EIH Reference 510(k) #: K220816 Reference Device Trade Name: BruxZir®…	Prismatik Dentalcraft, Inc.	2013	1
†	K220816	BruxZir NOW	Prismatik Dentalcraft, Inc.	2022	—

Also cleared against K130924: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 12.7 years on median.
1 of the 2 ancestors has a recall of any class.
3 other devices also cite its predicate K130924.

How does its category compare?

All EIH devices

EIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · EIH

13in 2025

2007high 28 (2024) · low 9 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EIH

84in 2025

2007high 187 (2016) · low 63 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EIH

1in 2025

2007high 21 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EIH

1in 2025

2007high 22 (2021) · low 0 (2007)2025

MAUDE reports naming product code EIH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	15	63	0	0
2008	15	87	0	1
2009	15	79	0	0
2010	14	89	0	0
2011	14	80	0	1
2012	9	96	0	0
2013	16	107	0	6
2014	18	118	0	1
2015	23	118	0	0
2016	22	187	21	4
2017	16	149	0	1
2018	10	139	0	2
2019	16	125	0	1
2020	13	155	0	0
2021	17	131	0	22
2022	16	89	0	0
2023	15	114	0	0
2024	28	89	0	7
2025	13	84	1	1
2026	14	73	0	—

What is it indicated for?

The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K254283 · printed Nov 6, 2026

Cite this page

510(k) Report. “K254283: BruxZir® Shaded 16 PLUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254283

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026