510(k) · Cleared
ClearedLava Frame, Lava Frame Shade, Lava Ceram
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe Dental AG · EIH Powder, Porcelain
Cleared on Jun 29, 2001 after a 53-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 40 later devices descend from it.
- Decided
- Jun 29, 2001
- Review
- 53 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 15 citing it directly.
- This deviceK011394 Lava Frame, Lava Frame Shade, Lava CeramEspe Dental AG · 2001
- Descendant · cites it directly · 16 of its ownK112710 Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR…Wieland Dental + Technik GmbH & Co. KG · 2011
- Descendant · cites it directly · 6 of its ownK111257 Heisenberg Dyeing Liquids3M Espe AG · 2011
- Descendant · 2 generations on · 5 of its ownK182833 ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier…The Argen Corporation · 2019
- Descendant · 2 generations on · 4 of its ownK140070 Luxer Shaded ZirconiaContinental Dental Ceramics, Inc. · 2014
- Descendant · 3 generations on · 3 of its ownK190518 Color Liquid, Vita LiquidZirkonzahn Srl · 2019
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K112710Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZRWieland Dental + Technik GmbH & Co. KG · 2011 · cites it directly16descendants
- K111257Heisenberg Dyeing Liquids3M Espe AG · 2011 · cites it directly6descendants
- K182833ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic ReducerThe Argen Corporation · 2019 · 2 generations on5descendants
- K140070Luxer Shaded ZirconiaContinental Dental Ceramics, Inc. · 2014 · 2 generations on4descendants
- K190518Color Liquid, Vita LiquidZirkonzahn Srl · 2019 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011394 | Lava Frame, Lava Frame Shade, Lava Ceram | Espe Dental AG | 2001 | — |
| +1 | K112710 | Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZR | Wieland Dental + Technik GmbH & Co. KG | 2011 | — |
| +1 | K111257 | Heisenberg Dyeing Liquids | 3M Espe AG | 2011 | — |
| +2 | K182833 | ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ… | The Argen Corporation | 2019 | — |
| +2 | K140070 | Luxer Shaded Zirconia | Continental Dental Ceramics, Inc. | 2014 | — |
| +3 | K190518 | Color Liquid, Vita Liquid | Zirkonzahn Srl | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (40)
See all 4015 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112710 | Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZR | 2011 | 16 |
| K111257 | Heisenberg Dyeing Liquids | 2011 | 6 |
| K120011 | Heisenberg Effect Shades | 2012 | 2 |
| K161922 | XP202 | 2016 | 1 |
| K132102 | Bece Cad Zirkon HT+ | 2013 | 1 |
| K092630 | ZIROX | 2009 | 1 |
| K092020 | Aadva ZR Coloring Liquid | 2009 | 1 |
| K090718 | Bellus Shading Kit | 2009 | 1 |
| K083201 | Zmatch Block | 2009 | 1 |
| K073314 | Heany Industries Inc Dental Xirconia | 2008 | 1 |
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?
- Of its descendants, K112710 (Wieland Dental + Technik GmbH & Co. KG, 2011) has gone furthest, with 16 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.
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 | — |
https://510kreport.com/device/K011394 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011394: Lava Frame, Lava Frame Shade, Lava Ceram.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011394
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026