510(k) · Cleared
ClearedBruxZir Anterior
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prismatik Dentalcraft, Inc. · EIH Powder, Porcelain
Cleared on Dec 15, 2014 as substantially equivalent to K130924 (Prismatik Dentalcraft, Inc., 2013) after a 25-day review. Its family tree reaches back 2 generations to 2006. 6 later devices descend from it.
- Decided
- Dec 15, 2014
- Review
- 25 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K060104 (2006). 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK060104 Prismatik Clinical ZirconiaGlidewell Laboratories · 2006
- 1 generation backK130924 Bruxzir ShadedPrismatik Dentalcraft, Inc. · 2013 · Recalled
- This deviceK143330 BruxZir AnteriorPrismatik Dentalcraft, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK162888 CerconDentsply Sirona · 2017
- Descendant · cites it directly · 1 of its ownK161219 Zmaxx T SeriesMaxx Digm, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK250826 Multi M SeriesDmax Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK241557 Cercon® yo MLDentsply Sirona · 2024
- Descendant · cites it directly · 0 of its ownK191902 Razor, Everest, U&C LiquidU&C International Co., Ltd. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K162888CerconDentsply Sirona · 2017 · cites it directly1descendant
- K161219Zmaxx T SeriesMaxx Digm, Inc. · 2017 · cites it directly1descendant
- K250826Multi M SeriesDmax Co., Ltd. · 2025 · 2 generations on0descendants
- K241557Cercon® yo MLDentsply Sirona · 2024 · 2 generations on0descendants
- K191902Razor, Everest, U&C LiquidU&C International Co., Ltd. · 2019 · cites it directly0descendants
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) | K143330 | BruxZir Anterior | Prismatik Dentalcraft, Inc. | 2014 | — |
| +1 | K162888 | Cercon | Dentsply Sirona | 2017 | — |
| +1 | K161219 | Zmaxx T Series | Maxx Digm, Inc. | 2017 | — |
| +2 | K250826 | Multi M Series | Dmax Co., Ltd. | 2025 | — |
| +2 | K241557 | Cercon® yo ML | Dentsply Sirona | 2024 | — |
| +1 | K191902 | Razor, Everest, U&C Liquid | U&C International Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K130924 | Bruxzir ShadedSummary page 4…ass II, EIH Panel: Dental C. IDENTIFICATION OF PREDICATE DEVICE Trade/Proprietary Name: BruxZir™ Shaded-K130924 Page 25 of 79 D. PROPOSED DEVICE DESCRIPTION BruxZir™ Anterior… | 2013 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K162888 (Dentsply Sirona, 2017) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K130924.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · EIH
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIH
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIH
1in 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/K143330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143330: BruxZir Anterior.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143330
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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