510(k) · Cleared
ClearedICE Ceramics, ICE Stains, Fresco
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zirkonzahn Srl · EIH Powder, Porcelain
Cleared on Dec 14, 2022 as substantially equivalent to K061851 (Zirkonzahn GmbH, 2006) after a 383-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Dec 14, 2022
- Review
- 383 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061851 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK061851 Zirkonzahn IceZirkonzahn GmbH · 2006
- This deviceK213722 ICE Ceramics, ICE Stains, FrescoZirkonzahn Srl · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061851 | Zirkonzahn Ice | Zirkonzahn GmbH | 2006 | — |
| 0 (this device) | K213722 | ICE Ceramics, ICE Stains, Fresco | Zirkonzahn Srl | 2022 | — |
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 |
|---|---|---|---|
| * | K061851 | Zirkonzahn IceSummary page 5…ED PREDICATE DEVICE Company: Zirkonzahn srl Device Name: Zirkonzahn Ice Product Code: EIH 510(k) Number: K061851 INDICATIONS FOR USE ICE CERAMICS, ICE CERAMICS TISSUE, ICE CERAMICS DENTINE +, ICE CERAMICS DYNAMIC DENTINE, FRESCO ENAMEL, FR… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K061851.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
ICE CERAMICS, ICE CERAMICS TISSUE, ICE CERAMICS DENTINE +, ICE CERAMICS DYNAMIC DENTINE, FRESCO ENAMEL, FRESCO GINGIVA, FRESCO, FRESCO DENTINE + and FRESCO DYNAMIC DENTINE are type I ceramics for coating, staining and glazing dental restorations made of final-sintered zirconia. They are conceived for patients who require dental restorations in zirconia, such as single crowns, bridges, inlays, onlays or veneers. ICE STAINS, ICE STAINS PRETTAU®, ICE STAINS…
Read the full statement (108 words)
ICE CERAMICS, ICE CERAMICS TISSUE, ICE CERAMICS DENTINE +, ICE CERAMICS DYNAMIC DENTINE, FRESCO ENAMEL, FRESCO GINGIVA, FRESCO, FRESCO DENTINE + and FRESCO DYNAMIC DENTINE are type I ceramics for coating, staining and glazing dental restorations made of final-sintered zirconia. They are conceived for patients who require dental restorations in zirconia, such as single crowns, bridges, inlays, onlays or veneers.
ICE STAINS, ICE STAINS PRETTAU®, ICE STAINS GLAZE FLUO and ICE STAINS 3D are type I ceramics for coating, staining and glazing dental restorations made of final-sintered zirconia. They are conceived for patients who require dental restorations in zirconia, such as single crowns, bridges, inlays, onlays or veneers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213722 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213722: ICE Ceramics, ICE Stains, Fresco.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213722
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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