510(k) · Cleared
ClearedHeisenberg Effect Shades
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe AG · EIH Powder, Porcelain
Cleared on Jan 13, 2012 as substantially equivalent to K011394 (Espe Dental AG, 2001) and 1 other predicate after a 10-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Jan 13, 2012
- Review
- 10 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011394 (2001). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK011394 Lava Frame, Lava Frame Shade, Lava CeramEspe Dental AG · 2001
- 1 generation backK112710 Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR…Wieland Dental + Technik GmbH & Co. KG · 2011
- This deviceK120011 Heisenberg Effect Shades3M Espe AG · 2012
- Descendant · cites it directly · 1 of its ownK161922 XP2023M Deutschland GmbH · 2016
- Descendant · 2 generations on · 0 of its ownK233158 Copra Smile, Copra Supreme HyperionWhitepeaks Dental Solutions GmbH · 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 | 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 | — |
| 0 (this device) | K120011 | Heisenberg Effect Shades | 3M Espe AG | 2012 | — |
| +1 | K161922 | XP202 | 3M Deutschland GmbH | 2016 | — |
| +2 | K233158 | Copra Smile, Copra Supreme Hyperion | Whitepeaks Dental Solutions GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K011394 | Lava Frame, Lava Frame Shade, Lava CeramSummary page 1…......... Effect shade Predicate Devices Lava'rm Frame Shade by 3M ESPE, Germany ...................................... K011394 Zenostar Color Zr by Wieland Dental + Technik GmbH & Co. KG, Germany ... Kl 12710 51 0(k) Submission: Heis… | 2001 |
| * | K112710 | Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZRSummary page 2…as the predicate devices LavaTh Frame Shades by 3M ESPE, Germany (KO0113 94) and Zenostar Color Zr by Wieland Dental + Technik, Germany (1(112710). 5 10(k) Submission: Heisenberg Effect Shades November 23, 2011 Page 15ot 3… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161922 | XP202 | 2016 | 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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K161922 (3M Deutschland GmbH, 2016) has gone furthest, with 1 descendant of its own.
- 14 other devices also cite its predicate K011394.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Heisenberg Effect Shades are suited for more intensive coloring of Heisenberg zirconia frameworks and Heisenberg all-zirconia restorations after basic dyeing using Heisenberg Dyeing Liquids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120011 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120011: Heisenberg Effect Shades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120011
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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