510(k) · Cleared
ClearedDcceram System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceramay GmbH & Co.Kg · EIH Powder, Porcelain
Cleared on Jan 28, 2015 as substantially equivalent to K111743 (Jensen Industries, Inc., 2011) and 2 other predicates after a 245-day review. Its family tree reaches back 4 generations to 2003. 3 later devices descend from it.
- Decided
- Jan 28, 2015
- Review
- 245 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K024250 (2003). 11 ancestors in all, the oldest K830955 (1983). 3 later devices descend from it, 2 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 deviceK141400 Dcceram SystemCeramay GmbH & Co.Kg · 2015
- Descendant · cites it directly · 1 of its ownK192251 Livento Press, Soprano 10, SopranoCendres+Metaux SA · 2020
- Descendant · 2 generations on · 0 of its ownK251084 zirkon; structure; LFU shades, stains and glazesEstetic Ceram AG · 2025
- Descendant · cites it directly · 0 of its ownK163228 APVolution SystemAesthetic-Press, LLC · 2017
Most influential descendants
Showing 3 of 3 · See allView 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) | K141400 | Dcceram System | Ceramay GmbH & Co.Kg | 2015 | — |
| +1 | K192251 | Livento Press, Soprano 10, Soprano | Cendres+Metaux SA | 2020 | — |
| +2 | K251084 | zirkon; structure; LFU shades, stains and glazes | Estetic Ceram AG | 2025 | — |
| +1 | K163228 | APVolution System | Aesthetic-Press, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 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? (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 |
|---|---|---|---|
| * | K111743 | The Insync Ceramic SystemSummary page 4…Porcelain Powder for Clinical Use Class I In-Sync Ceramic System (Jensen Industries) Dental Ceramic EIH 21 CFR 872.6660 — Porcelain Powder for Clinical Use Class Il K111743 Willi Geller Creation CP L&M Porcelain (Jensen Industrties) Dental Ceramic EIH 21 CFR 872.6660 — Porcelain Powder for Clinical… | 2011 |
| * | K002904 | Willi Geller Creation and LF PorcelainSummary page 4…ical Use Class Il K111743 Willi Geller Creation CP L&M Porcelain (Jensen Industrties) Dental Ceramic EIH 21 CFR 872.6660 — Porcelain Powder for Clinical Use Class I K002904 OPC 3G All-Ceramic System (Jeneric/Pentron) Dental Ceramic EIH 21 CFR 872.6660 — Porcelain Powder for Clinical Use Class Il K… | 2000 |
| * | K994435 | Opc 3G All-Ceramic System, Core and Overlay PorcelainsSummary page 4…Powder for Clinical Use Class I K002904 OPC 3G All-Ceramic System (Jeneric/Pentron) Dental Ceramic EIH 21 CFR 872.6660 — Porcelain Powder for Clinical Use Class Il K994435 21 Ceramay GmbH & Co. KG July 14, 2014 K141400/Amendment 1 DCceram System Indications for Use The DCceram Syst… | 2000 |
What descends from it? (3)
2 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 12 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K192251 (Cendres+Metaux SA, 2020) has gone furthest, with 1 descendant 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. 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?
The DCceram System is used to fabricate prostheses for missing/damaged teeth. The DCceram pressable ceramic ingots are pressed onto metal alloy (DCceram 12.5) or zirconia (DCceram 9.2) frames by dental technicians to fabricate ceramic restorations. DCceram 12.5 and DCceram 9.2 ceramic layering porcelains and shades are used to layer or build up the pressed ceramic to final tooth morphology and shade on the particular framework (DCceram 9.2 zirconia substructures: Deceram 12.5 metal substructures). The DCceram conceptPress ceramic ingots are used to fabricate all-ceramic restorations. DCceram conceptArt ceramic stains and shades may be used with DCceram conceptPress or DCeeram 9.2 ceramics.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141400: Dcceram System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141400
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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