510(k) · Cleared
ClearedCeram X Universal Mano-Ceramic Restorative
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International · EBF Material, Tooth Shade, Resin
Cleared on Aug 12, 2005 as substantially equivalent to K984387 (Dentsply Intl., 1999) after a 9-day review. Its family tree reaches back 3 generations to 1986. 2 later devices descend from it.
- Decided
- Aug 12, 2005
- Review
- 9 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K863092 (1986). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK863092 Dental Composite RestorativeDentsply Intl. · 1986
- 2 generations backK973221 Composite 168 Restorative SystemDentsply Intl. · 1998
- 1 generation backK984387 R-30 Aesthetic RestorativeDentsply Intl. · 1999
- This deviceK052097 Ceram X Universal Mano-Ceramic RestorativeDentsply International · 2005
- Descendant · cites it directly · 1 of its ownK080305 Nexcomp and Meta EtchantMeta Biomed Co., Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK181689 NexcompMeta Biomed Co., Ltd. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K863092 | Dental Composite Restorative | Dentsply Intl. | 1986 | — |
| −2 | K973221 | Composite 168 Restorative System | Dentsply Intl. | 1998 | — |
| −1 | K984387 | R-30 Aesthetic Restorative | Dentsply Intl. | 1999 | — |
| 0 (this device) | K052097 | Ceram X Universal Mano-Ceramic Restorative | Dentsply International | 2005 | — |
| +1 | K080305 | Nexcomp and Meta Etchant | Meta Biomed Co., Ltd. | 2008 | — |
| +2 | K181689 | Nexcomp | Meta Biomed Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2018 | 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 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 |
|---|---|---|---|
| * | K984387 | R-30 Aesthetic RestorativeSummary page 1…O-CERAMJC"rM RESTORATIVE CLASSIFICATION NAME: Tooth shade resin material, 872.3690 PREDICATE DEVICES: R-30 Aesthetic Restorative, K984387 DEVICE DESCRIPTION: The UNIVERSAL NANO-CERAMICim RESTORATIVE is a light-cured, radiopaque, dental restorative product for use… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080305 | Nexcomp and Meta Etchant | 2008 | 1 |
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 19 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K080305 (Meta Biomed Co., Ltd., 2008) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
UNIVERSAL NANO-CERAMICTM RESTORATIVE is indicated for direct restorations of all cavity classes in anterior and posterior teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052097 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052097: Ceram X Universal Mano-Ceramic Restorative.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052097
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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