510(k) · Cleared
ClearedBruxZir Esthetic
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 Nov 17, 2021 as substantially equivalent to K130924 (Prismatik Dentalcraft, Inc., 2013) after a 27-day review. Its family tree reaches back 2 generations to 2006. 2 later devices descend from it.
- Decided
- Nov 17, 2021
- Review
- 27 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K060104 (2006). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK060104 Prismatik Clinical ZirconiaGlidewell Laboratories · 2006
- 1 generation backK130924 Bruxzir ShadedPrismatik Dentalcraft, Inc. · 2013 · Recalled
- This deviceK213425 BruxZir EstheticPrismatik Dentalcraft, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK233064 Copra SupremeWhitepeaks Dental Solutions GmbH · 2024
- Descendant · cites it directly · 0 of its ownK240882 BruxZir® EstheticPrismatik Dentalcraft, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView 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) | K213425 | BruxZir Esthetic | Prismatik Dentalcraft, Inc. | 2021 | — |
| +1 | K233064 | Copra Supreme | Whitepeaks Dental Solutions GmbH | 2024 | — |
| +1 | K240882 | BruxZir® Esthetic | Prismatik Dentalcraft, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 5…r clinical use (21 CFR 872.6660) Regulatory Class: Class II Product Code: EIH III. PREDICATE DEVICE BruxZir® Shaded (K130924) IV. DEVICE DESCRIPTION BruxZir® Esthetic blanks are zirconia milling blanks used for the production of… | 2013 |
What descends from it? (2)
2 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 15 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K233064 (Whitepeaks Dental Solutions GmbH, 2024) has gone furthest, with 0 descendants 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. 2021, 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/K213425 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213425: BruxZir Esthetic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213425
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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