510(k) · Cleared
ClearedDD Bio Z and DD Bio Z - Transpa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dental Direkt of Amerika UG (Haftungsbeschraenkt) · EIH Powder, Porcelain
Cleared on Feb 24, 2010 as substantially equivalent to K081263 (H.C. Starck Ceramics GmbH & Co.Kg, 2008) and 2 other predicates after an 82-day review. Its family tree reaches back 7 generations to 1983. 13 later devices descend from it.
- Decided
- Feb 24, 2010
- Review
- 82 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K830955 (1983). 22 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 6 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 5 generations backK984201 DenzirDentronic AB · 1999
- 4 generations backK023327 Cynovad ZirkonCynovad · 2002
- 3 generations backK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- 2 generations backK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- 1 generation backK081263 StarceramH.C. Starck Ceramics GmbH & Co.Kg · 2008
- This deviceK093748 DD Bio Z and DD Bio Z - TranspaDental Direkt of Amerika UG (Haftungsbeschraenkt) · 2010
- Descendant · cites it directly · 9 of its ownK150196 DD cubeX2Dental Direkt GmbH · 2015
- Descendant · cites it directly · 7 of its ownK142987 DD Bio Z, DD Bio ZX (square), DD BioZX (square) colorDental Direkt of Amerika UG (Haftungsbeschraenkt) · 2015
- Descendant · 2 generations on · 5 of its ownK171585 LUXEN Zr, LUXEN SmileDentalmax Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK241151 Luxen 5GDentalmax Co., Ltd. · 2024
- Descendant · 3 generations on · 1 of its ownK210097 Estar-ZOsstem Implant Co., Ltd. · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K150196DD cubeX2Dental Direkt GmbH · 2015 · cites it directly9descendants
- K142987DD Bio Z, DD Bio ZX (square), DD BioZX (square) colorDental Direkt of Amerika UG (Haftungsbeschraenkt) · 2015 · cites it directly7descendants
- K171585LUXEN Zr, LUXEN SmileDentalmax Co., Ltd. · 2018 · 2 generations on5descendants
- K241151Luxen 5GDentalmax Co., Ltd. · 2024 · 3 generations on1descendant
- K210097Estar-ZOsstem Implant Co., Ltd. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −6 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −5 | K984201 | Denzir | Dentronic AB | 1999 | — |
| −4 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| −3 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| −2 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| −1 | K081263 | Starceram | H.C. Starck Ceramics GmbH & Co.Kg | 2008 | — |
| 0 (this device) | K093748 | DD Bio Z and DD Bio Z - Transpa | Dental Direkt of Amerika UG (Haftungsbeschraenkt) | 2010 | — |
| +1 | K150196 | DD cubeX2 | Dental Direkt GmbH | 2015 | — |
| +1 | K142987 | DD Bio Z, DD Bio ZX (square), DD BioZX (square) color | Dental Direkt of Amerika UG (Haftungsbeschraenkt) | 2015 | — |
| +2 | K171585 | LUXEN Zr, LUXEN Smile | Dentalmax Co., Ltd. | 2018 | — |
| +3 | K241151 | Luxen 5G | Dentalmax Co., Ltd. | 2024 | — |
| +3 | K210097 | Estar-Z | Osstem Implant Co., Ltd. | 2021 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K081263 | StarceramSummary page 1…(21 CFR 872.6660, Product Code EIH) Classification Class 11 Predicate Devices K081263 H.C. Starck Ceramics StarCeram K051462 DENTSPILY International Cercon Base… | 2008 |
| * | K051462 | Modification to: Cercon BaseSummary page 1…Class 11 Predicate Devices K081263 H.C. Starck Ceramics StarCeram K051462 DENTSPILY International Cercon Base K072569 Metoxit CAM blanks Device… | 2005 |
| * | K072569 | Metoxit Cam-BlanksSummary page 1…. Starck Ceramics StarCeram K051462 DENTSPILY International Cercon Base K072569 Metoxit CAM blanks Device Description and Dental Blanks made of DO 81o Z or DD Bio Z-transpa… | 2007 |
What descends from it? (13)
See all 133 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 27 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K150196 (Dental Direkt GmbH, 2015) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K081263.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Bio Z or DD Bio Z-transpa are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093748 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093748: DD Bio Z and DD Bio Z - Transpa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093748
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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