510(k) · Cleared
ClearedDD cubeX2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dental Direkt GmbH · EIH Powder, Porcelain
Cleared on Mar 26, 2015 as substantially equivalent to K093748 (Dental Direkt of Amerika UG (Haftungsbeschraenkt), 2010) after a 56-day review. Its family tree reaches back 8 generations to 1983. 9 later devices descend from it.
- Decided
- Mar 26, 2015
- Review
- 56 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K830955 (1983). 23 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 7 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 6 generations backK984201 DenzirDentronic AB · 1999
- 5 generations backK023327 Cynovad ZirkonCynovad · 2002
- 4 generations backK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- 3 generations backK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- 2 generations backK081263 StarceramH.C. Starck Ceramics GmbH & Co.Kg · 2008
- 1 generation backK093748 DD Bio Z and DD Bio Z - TranspaDental Direkt of Amerika UG (Haftungsbeschraenkt) · 2010
- This deviceK150196 DD cubeX2Dental Direkt GmbH · 2015
- Descendant · cites it directly · 5 of its ownK171585 LUXEN Zr, LUXEN SmileDentalmax Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK241151 Luxen 5GDentalmax Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK210097 Estar-ZOsstem Implant Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK262074 Any-ZircosMediclus Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK242521 Estar-ZEOsstem Implant Co., Ltd. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K171585LUXEN Zr, LUXEN SmileDentalmax Co., Ltd. · 2018 · cites it directly5descendants
- K241151Luxen 5GDentalmax Co., Ltd. · 2024 · 2 generations on1descendant
- K210097Estar-ZOsstem Implant Co., Ltd. · 2021 · 2 generations on1descendant
- K262074Any-ZircosMediclus Co., Ltd. · 2026 · 2 generations on0descendants
- K242521Estar-ZEOsstem Implant Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −7 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −6 | K984201 | Denzir | Dentronic AB | 1999 | — |
| −5 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| −4 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| −3 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| −2 | K081263 | Starceram | H.C. Starck Ceramics GmbH & Co.Kg | 2008 | — |
| −1 | K093748 | DD Bio Z and DD Bio Z - Transpa | Dental Direkt of Amerika UG (Haftungsbeschraenkt) | 2010 | — |
| 0 (this device) | K150196 | DD cubeX2 | Dental Direkt GmbH | 2015 | — |
| +1 | K171585 | LUXEN Zr, LUXEN Smile | Dentalmax Co., Ltd. | 2018 | — |
| +2 | K241151 | Luxen 5G | Dentalmax Co., Ltd. | 2024 | — |
| +2 | K210097 | Estar-Z | Osstem Implant Co., Ltd. | 2021 | — |
| +2 | K262074 | Any-Zircos | Mediclus Co., Ltd. | 2026 | — |
| +3 | K242521 | Estar-ZE | Osstem Implant Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K093748 | DD Bio Z and DD Bio Z - TranspaSummary page 4…21 CFR 872.6660 Product Code EIH Panel Dental Classification Class II Name of legally DD Bio Z-transpa (K093748) marketed device Indications for Use Dental blanks made from DD cubeX2 are indicated for crowns,… | 2010 |
What descends from it? (9)
4 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 32 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 23 ancestors has a recall of any class.
- Of its descendants, K171585 (Dentalmax Co., Ltd., 2018) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K093748.
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?
Dental blanks made from DD cubeX2 are indicated for crowns, multi-unit bridges (up to a maximum of 3 elements) and inlay bridges. Applications include both, anterior and posterior bridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150196: DD cubeX2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150196
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