510(k) · Cleared
ClearedDD Contrast
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 Apr 16, 2020 as substantially equivalent to K111743 (Jensen Industries, Inc., 2011) after a 115-day review. Its family tree reaches back 4 generations to 2003. 1 later device descends from it.
- Decided
- Apr 16, 2020
- Review
- 115 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K024250 (2003). 6 ancestors in all, the oldest K002041 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK024250 Match Press Pressable CeramicDavis Schottlander & Davis, Ltd. · 2003
- 3 generations backK043221 Willi Geller Creation CP PorcelainJensen Industries, Inc. · 2004
- 2 generations backK070114 Creation CP-ZI PorcelainJensen Industries, Inc. · 2007
- 1 generation backK111743 The Insync Ceramic SystemJensen Industries, Inc. · 2011
- This deviceK193588 DD ContrastDental Direkt GmbH · 2020
- Descendant · cites it directly · 0 of its ownK231264 Easy On Universal Glaze & StainDoctus Global · 2023
Most influential descendants
Showing 1 of 1 · See all- K231264Easy On Universal Glaze & StainDoctus Global · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K024250 | Match Press Pressable Ceramic | Davis Schottlander & Davis, Ltd. | 2003 | — |
| −3 | K043221 | Willi Geller Creation CP Porcelain | Jensen Industries, Inc. | 2004 | — |
| −2 | K070114 | Creation CP-ZI Porcelain | Jensen Industries, Inc. | 2007 | — |
| −1 | K111743 | The Insync Ceramic System | Jensen Industries, Inc. | 2011 | — |
| 0 (this device) | K193588 | DD Contrast | Dental Direkt GmbH | 2020 | — |
| +1 | K231264 | Easy On Universal Glaze & Stain | Doctus Global | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K111743 | The Insync Ceramic SystemSummary page 5…6 Page 2 of 7 Dental Direkt GmbH, 32139 Spenge, Germany Primary Predicate Device K111743: Jensen Industries: InSync Ceramic System (Model name: “MiYO – liquid… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231264 | Easy On Universal Glaze & Stain | 2023 | 0 |
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 17 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K231264 (Doctus Global, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K111743.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The DD contrast® veneering ceramics system is suitable for the esthetic individualization of monolithic or minimally reduced dental crown and bridge constructions made of zirconium dioxide or lithium disilicate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193588: DD Contrast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193588
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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