510(k) · Cleared
ClearedThe Insync Ceramic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jensen Industries, Inc. · EIH Powder, Porcelain
Cleared on Sep 14, 2011 as substantially equivalent to K043221 (Jensen Industries, Inc., 2004) and 1 other predicate after an 85-day review. Its family tree reaches back 3 generations to 2003. 7 later devices descend from it.
- Decided
- Sep 14, 2011
- Review
- 85 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K024250 (2003). 5 ancestors in all, the oldest K002041 (2000). 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK024250 Match Press Pressable CeramicDavis Schottlander & Davis, Ltd. · 2003
- 2 generations backK043221 Willi Geller Creation CP PorcelainJensen Industries, Inc. · 2004
- 1 generation backK070114 Creation CP-ZI PorcelainJensen Industries, Inc. · 2007
- This deviceK111743 The Insync Ceramic SystemJensen Industries, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK141400 Dcceram SystemCeramay GmbH & Co.Kg · 2015
- Descendant · cites it directly · 1 of its ownK193588 DD ContrastDental Direkt GmbH · 2020
- Descendant · 2 generations on · 1 of its ownK192251 Livento Press, Soprano 10, SopranoCendres+Metaux SA · 2020
- Descendant · 3 generations on · 0 of its ownK251084 zirkon; structure; LFU shades, stains and glazesEstetic Ceram AG · 2025
- Descendant · 2 generations on · 0 of its ownK231264 Easy On Universal Glaze & StainDoctus Global · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K141400Dcceram SystemCeramay GmbH & Co.Kg · 2015 · cites it directly3descendants
- K193588DD ContrastDental Direkt GmbH · 2020 · cites it directly1descendant
- K192251Livento Press, Soprano 10, SopranoCendres+Metaux SA · 2020 · 2 generations on1descendant
- K251084zirkon; structure; LFU shades, stains and glazesEstetic Ceram AG · 2025 · 3 generations on0descendants
- K231264Easy On Universal Glaze & StainDoctus Global · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K024250 | Match Press Pressable Ceramic | Davis Schottlander & Davis, Ltd. | 2003 | — |
| −2 | K043221 | Willi Geller Creation CP Porcelain | Jensen Industries, Inc. | 2004 | — |
| −1 | K070114 | Creation CP-ZI Porcelain | Jensen Industries, Inc. | 2007 | — |
| 0 (this device) | K111743 | The Insync Ceramic System | Jensen Industries, Inc. | 2011 | — |
| +1 | K141400 | Dcceram System | Ceramay GmbH & Co.Kg | 2015 | — |
| +1 | K193588 | DD Contrast | Dental Direkt GmbH | 2020 | — |
| +2 | K192251 | Livento Press, Soprano 10, Soprano | Cendres+Metaux SA | 2020 | — |
| +3 | K251084 | zirkon; structure; LFU shades, stains and glazes | Estetic Ceram AG | 2025 | — |
| +2 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K043221 | Willi Geller Creation CP PorcelainSummary page 1…inical use (21 CFR 872.6660) Classification: Class 11 Product Code: EIH Predicate Devices Ceramics 2inl1: 510(k) number K043221 WVith Gelter Creation CP - ZI: 510(k) number K070 114 Device Description The In, vnc Ceramic System… | 2004 |
| * | K070114 | Creation CP-ZI PorcelainSummary page 1…EIH Predicate Devices Ceramics 2inl1: 510(k) number K043221 WVith Gelter Creation CP - ZI: 510(k) number K070 114 Device Description The In, vnc Ceramic System consists of pressable silica based ceramic pellets and silica based ceramic layer… | 2007 |
What descends from it? (7)
3 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 8 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K141400 (Ceramay GmbH & Co.Kg, 2015) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K043221.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 pressable ceramic pellets are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and the ceramic layering porcelain and liquids are used to build up the pressed ceramic to final tooth morphology and shade. The ceramic layering porcelain and liquids are also used in building ceramic crowns and bridges on titanium and titanium alloy substructures. Both applications are to provise protheses for missing / damaged teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111743: The Insync Ceramic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111743
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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