510(k) · Cleared
ClearedLUXEN Zr, LUXEN Smile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentalmax Co., Ltd. · EIH Powder, Porcelain
Cleared on Oct 31, 2018 as substantially equivalent to K142987 (Dental Direkt of Amerika UG (Haftungsbeschraenkt), 2015) and 1 other predicate after a 518-day review. Its family tree reaches back 9 generations to 1983. 5 later devices descend from it.
- Decided
- Oct 31, 2018
- Review
- 518 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K830955 (1983). 25 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 5 generations between
- 3 generations backK081263 StarceramH.C. Starck Ceramics GmbH & Co.Kg · 2008
- 2 generations backK093748 DD Bio Z and DD Bio Z - TranspaDental Direkt of Amerika UG (Haftungsbeschraenkt) · 2010
- 1 generation backK142987 DD Bio Z, DD Bio ZX (square), DD BioZX (square) colorDental Direkt of Amerika UG (Haftungsbeschraenkt) · 2015
- This deviceK171585 LUXEN Zr, LUXEN SmileDentalmax Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK241151 Luxen 5GDentalmax Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK210097 Estar-ZOsstem Implant Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK262074 Any-ZircosMediclus Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK242521 Estar-ZEOsstem Implant Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK221429 KDF Zirconia DiscDenken-Highdental Co., Ltd. · 2022
Show all 9 generations
- Root · 9 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 8 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 7 generations backK984201 DenzirDentronic AB · 1999
- 6 generations backK023327 Cynovad ZirkonCynovad · 2002
- 5 generations backK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- 4 generations backK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- 3 generations backK081263 StarceramH.C. Starck Ceramics GmbH & Co.Kg · 2008
- 2 generations backK093748 DD Bio Z and DD Bio Z - TranspaDental Direkt of Amerika UG (Haftungsbeschraenkt) · 2010
- 1 generation backK142987 DD Bio Z, DD Bio ZX (square), DD BioZX (square) colorDental Direkt of Amerika UG (Haftungsbeschraenkt) · 2015
- This deviceK171585 LUXEN Zr, LUXEN SmileDentalmax Co., Ltd. · 2018
Most influential descendants
Showing 5 of 5 · See all- K241151Luxen 5GDentalmax Co., Ltd. · 2024 · cites it directly1descendant
- K210097Estar-ZOsstem Implant Co., Ltd. · 2021 · cites it directly1descendant
- K262074Any-ZircosMediclus Co., Ltd. · 2026 · cites it directly0descendants
- K242521Estar-ZEOsstem Implant Co., Ltd. · 2024 · 2 generations on0descendants
- K221429KDF Zirconia DiscDenken-Highdental Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −8 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −7 | K984201 | Denzir | Dentronic AB | 1999 | — |
| −6 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| −5 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| −4 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| −3 | K081263 | Starceram | H.C. Starck Ceramics GmbH & Co.Kg | 2008 | — |
| −2 | K093748 | DD Bio Z and DD Bio Z - Transpa | Dental Direkt of Amerika UG (Haftungsbeschraenkt) | 2010 | — |
| −1 | K142987 | DD Bio Z, DD Bio ZX (square), DD BioZX (square) color | Dental Direkt of Amerika UG (Haftungsbeschraenkt) | 2015 | — |
| 0 (this device) | K171585 | LUXEN Zr, LUXEN Smile | Dentalmax Co., Ltd. | 2018 | — |
| +1 | K241151 | Luxen 5G | Dentalmax Co., Ltd. | 2024 | — |
| +1 | K210097 | Estar-Z | Osstem Implant Co., Ltd. | 2021 | — |
| +1 | K262074 | Any-Zircos | Mediclus Co., Ltd. | 2026 | — |
| +2 | K242521 | Estar-ZE | Osstem Implant Co., Ltd. | 2024 | — |
| +1 | K221429 | KDF Zirconia Disc | Denken-Highdental Co., Ltd. | 2022 | — |
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 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K142987 | DD Bio Z, DD Bio ZX (square), DD BioZX (square) colorSummary page 4…use Classification regulation: 872.6660 Regulatory Class: 2 Product Code: EIH III. PREDICATE DEVICE K142987, DD Bio ZX2, Dental Direkt of Amerika UG K142987, DD cube X2, Dental Direkt of Amerika UG IV. DEVICE DESCRIPTION… | 2015 |
| * | K150196 | DD cubeX2Summary page 8…ube X2 - Manufacturer DENTALMAX CO., Ltd. Dental Direkt GmbH - 510(k) Number K171585 K150196 - Classification Name Porcelain powder for Porcelain powder for Both products… | 2015 |
What descends from it? (5)
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 35 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K241151 (Dentalmax Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K142987.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
LUXEN Zr is indicated for the production of all-ceramic inlays, multi-units bridges, onlays, and veneers without zirconium dioxide frameworks.
LUXEN Smile is indicated for the production of full ceramic crowns, onlays, 3-bridges and inlay bridges (anterior and molar).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171585: LUXEN Zr, LUXEN Smile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171585
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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