510(k) · Cleared
ClearedZmaxx T Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxx Digm, Inc. · EIH Powder, Porcelain
Cleared on Jan 26, 2017 as substantially equivalent to K091096 (Dental Solutions, Inc., 2009) and 1 other predicate after a 272-day review. Its family tree reaches back 3 generations to 2002. 1 later device descends from it.
- Decided
- Jan 26, 2017
- Review
- 272 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K022996 (2002). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK022996 Vita in-Ceram YZ Cubes for CerecVident · 2002
- 2 generations backK032081 Kavo Everest ZS-Blank Models, 42, 20, and 60Kavo America · 2003
- 1 generation backK091096 Naturaz Series, Model B16,B20, B42, B60, B98, B100Dental Solutions, Inc. · 2009
- This deviceK161219 Zmaxx T SeriesMaxx Digm, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK250826 Multi M SeriesDmax Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250826Multi M SeriesDmax Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022996 | Vita in-Ceram YZ Cubes for Cerec | Vident | 2002 | — |
| −2 | K032081 | Kavo Everest ZS-Blank Models, 42, 20, and 60 | Kavo America | 2003 | — |
| −1 | K091096 | Naturaz Series, Model B16,B20, B42, B60, B98, B100 | Dental Solutions, Inc. | 2009 | — |
| 0 (this device) | K161219 | Zmaxx T Series | Maxx Digm, Inc. | 2017 | — |
| +1 | K250826 | Multi M Series | Dmax Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K091096 | Naturaz Series, Model B16,B20, B42, B60, B98, B100Summary page 4…ion: Class II, 21 CFR 872.6660 Classification Product Code: EIH 4. Predicate Device: Primary Predicate Device: NATURAZ SERIES (K091096) by The Dental Solutions, Inc. Reference Predicate Device: BruxZir™ Anterior (K143330) by Prismatik Dentalcraft, Inc.… | 2009 |
| * | K143330 | BruxZir AnteriorSummary page 4…IH 4. Predicate Device: Primary Predicate Device: NATURAZ SERIES (K091096) by The Dental Solutions, Inc. Reference Predicate Device: BruxZir™ Anterior (K143330) by Prismatik Dentalcraft, Inc. 1 5. Device Description:… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250826 | Multi M Series | 2025 | 0 |
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 4 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K250826 (Dmax Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Zmaxx T Series is used in the manufacture of dental prosthetics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161219: Zmaxx T Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161219
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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