510(k) · Cleared
ClearedCeramill Zolid FX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emergo Europe Consulting · EIH Powder, Porcelain
Cleared on Sep 21, 2015 as substantially equivalent to K063511 (Amann Girrbach America, Inc., 2007) after a 28-day review. Its family tree reaches back 3 generations to 1998. 3 later devices descend from it.
- Decided
- Sep 21, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K980986 (1998). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK980986 ProcadIvoclar USA, Inc. · 1998
- 2 generations backK053438 Glass Ceramics3M Espe AG Dental Products · 2006
- 1 generation backK063511 Ceramill ZIAmann Girrbach America, Inc. · 2007
- This deviceK152383 Ceramill Zolid FXEmergo Europe Consulting · 2015
- Descendant · cites it directly · 1 of its ownK170050 Z-CAD smileMetoxit AG · 2018
- Descendant · 2 generations on · 0 of its ownK222836 Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG · 2023 · Recalled
- Descendant · cites it directly · 0 of its ownK173971 K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2…Yeti Dentalprodukte GmbH · 2018
Most influential descendants
Showing 3 of 3 · See all- K170050Z-CAD smileMetoxit AG · 2018 · cites it directly1descendant
- K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG · 2023 · 2 generations on0descendants
- K173971K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucentYeti Dentalprodukte GmbH · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980986 | Procad | Ivoclar USA, Inc. | 1998 | — |
| −2 | K053438 | Glass Ceramics | 3M Espe AG Dental Products | 2006 | — |
| −1 | K063511 | Ceramill ZI | Amann Girrbach America, Inc. | 2007 | — |
| 0 (this device) | K152383 | Ceramill Zolid FX | Emergo Europe Consulting | 2015 | — |
| +1 | K170050 | Z-CAD smile | Metoxit AG | 2018 | — |
| +2 | K222836 | Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | Institut Straumann AG | 2023 | 1 |
| +1 | K173971 | K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme… | Yeti Dentalprodukte GmbH | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K063511 | Ceramill ZISummary page 4…Class II Classification Panel: Dental 5. Legally Marketed Predicate Device(s) Amann Girrbach America, Inc. Ceramill ZI blanks 510(K) Number K063511. Page5‐1 6. Device Description Amann Girrbach AG “Ceramill Z… | 2007 |
What descends from it? (3)
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 17 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K170050 (Metoxit AG, 2018) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K063511.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
“Ceramill Zolid FX" preshade are blanks made of zirconium oxide (ZrO2) for type 11, class 5 dental applications in accordance with DIN EN ISO 6872. They are used for manufacturing permanent and removable prosthetic restorations (e.g., crowns and three-unit bridges to the molar region) using CNC milling machines (e.g., Ceramill Motion).
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/K152383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152383: Ceramill Zolid FX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152383
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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