510(k) · Cleared
ClearedEnamic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vita Zahnfabrik H.Rauter GmbH & Co. · EIH Powder, Porcelain
Cleared on Dec 13, 2012 as substantially equivalent to K102128 (Vita Zahnfabrik H.Rauter GmbH & Co., 2010) and 1 other predicate after a 136-day review. Its family tree reaches back 2 generations to 1992. 3 later devices descend from it.
- Decided
- Dec 13, 2012
- Review
- 136 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K920425 (1992). 4 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK920425 3M Brand Restorative Z1003M Company · 1992
- 1 generation backK110131 Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate…3M Espe Dental Products · 2011 · Recalled
- This deviceK122269 EnamicVita Zahnfabrik H.Rauter GmbH & Co. · 2012
- Descendant · cites it directly · 0 of its ownK243940 VITA YZ Multi TranslucentVita Zahnfabrik H.Rauter GmbH & Co. · 2025
- Descendant · cites it directly · 0 of its ownK153645 VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co. · 2016
- Descendant · cites it directly · 0 of its ownK130654 Crystal UltraDental Laboratory Milling Supplies, LLC (Dlms) · 2013
Most influential descendants
Showing 3 of 3 · See all- K243940VITA YZ Multi TranslucentVita Zahnfabrik H.Rauter GmbH & Co. · 2025 · cites it directly0descendants
- K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co. · 2016 · cites it directly0descendants
- K130654Crystal UltraDental Laboratory Milling Supplies, LLC (Dlms) · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920425 | 3M Brand Restorative Z100 | 3M Company | 1992 | — |
| −1 | K110131 | Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown… | 3M Espe Dental Products | 2011 | 1 |
| 0 (this device) | K122269 | Enamic | Vita Zahnfabrik H.Rauter GmbH & Co. | 2012 | — |
| +1 | K243940 | VITA YZ Multi Translucent | Vita Zahnfabrik H.Rauter GmbH & Co. | 2025 | — |
| +1 | K153645 | VITA ENAMIC Implant Solutions (IS) | Vita Zahnfabrik H.Rauter GmbH Co. | 2016 | — |
| +1 | K130654 | Crystal Ultra | Dental Laboratory Milling Supplies, LLC (Dlms) | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K102128 | VitablocsSummary page 1…872.6660, Product Code: EIH) " Secondary Classification Name: Tooth Shade Resin Material (21 CFR 872.3690, Product Code: EBF) Predicate Devices: VitablocsO 510(k) 102128 and * Lava Ultimate CAD/CAM Restorative for Cerec/ E4D), Lava Ultimate Implant Crown Restorativ… | 2010 |
| * | K110131 | Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown RestorativeSummary page 1…vices: VitablocsO 510(k) 102128 and * Lava Ultimate CAD/CAM Restorative for Cerec/ E4D), Lava Ultimate Implant Crown Restorative 510(k) 110131 Device Description The Vita EnamicO block consists of interpenetrating networks of ceramic and polymer. material… | 2011 |
What descends from it? (3)
3 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 20 years and passes through 3 companies; a new generation was cleared every 18.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K243940 (Vita Zahnfabrik H.Rauter GmbH & Co., 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. 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?
EnamicO is indicated for use as a dental restoration including inlays, onlays, veneers, and crowns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122269 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122269: Enamic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122269
Report an extraction error
Are you the manufacturer?
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