510(k) · Cleared
Recalled · Class II · 2016Bruxzir Shaded
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 May 16, 2013 as substantially equivalent to K060104 (Glidewell Laboratories, 2006) after a 43-day review. Its family tree reaches back 1 generation to 2006. 12 later devices descend from it. It has been recalled once.
- Decided
- May 16, 2013
- Review
- 43 days
- Class
- Class II
- Product code
- EIH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060104 (2006). 12 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK060104 Prismatik Clinical ZirconiaGlidewell Laboratories · 2006
- This deviceK130924 Bruxzir ShadedPrismatik Dentalcraft, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK143330 BruxZir AnteriorPrismatik Dentalcraft, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK213425 BruxZir EstheticPrismatik Dentalcraft, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK162888 CerconDentsply Sirona · 2017
- Descendant · 2 generations on · 1 of its ownK161219 Zmaxx T SeriesMaxx Digm, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK254283 BruxZir® Shaded 16 PLUSPrismatik Dentalcraft, Inc. · 2026
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K143330BruxZir AnteriorPrismatik Dentalcraft, Inc. · 2014 · cites it directly6descendants
- K213425BruxZir EstheticPrismatik Dentalcraft, Inc. · 2021 · cites it directly2descendants
- K162888CerconDentsply Sirona · 2017 · 2 generations on1descendant
- K161219Zmaxx T SeriesMaxx Digm, Inc. · 2017 · 2 generations on1descendant
- K254283BruxZir® Shaded 16 PLUSPrismatik Dentalcraft, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060104 | Prismatik Clinical Zirconia | Glidewell Laboratories | 2006 | — |
| 0 (this device) | K130924 | Bruxzir Shaded | Prismatik Dentalcraft, Inc. | 2013 | — |
| +1 | K143330 | BruxZir Anterior | Prismatik Dentalcraft, Inc. | 2014 | — |
| +1 | K213425 | BruxZir Esthetic | Prismatik Dentalcraft, Inc. | 2021 | — |
| +2 | K162888 | Cercon | Dentsply Sirona | 2017 | — |
| +2 | K161219 | Zmaxx T Series | Maxx Digm, Inc. | 2017 | — |
| +1 | K254283 | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K060104 | Prismatik Clinical ZirconiaSummary page 1…Dental C. IDENTIFICATION OF PREDICATE DEVICE Trade/Proprietary Name: Prismatik Tm Clinical Zirconia (Prismatik Tm CZ)-K060 104 41 Page 25 of 142 SiPRISMATIK SIDENTAICRAFT, INC. D. DEVICE DESCRIPTIO… | 2006 |
What descends from it? (12)
See all 124 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 15, 2016 | Class II | Z-2897-2016 | Release of Material/Component prior to receiving test results | Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly identify the lots as quarantined product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 as stated in the FDA summary.
https://510kreport.com/device/K130924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130924: Bruxzir Shaded.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130924
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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