510(k) · Cleared
ClearedXeracem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Doxa Dental AB · EMA Cement, Dental
Cleared on Aug 21, 2008 as substantially equivalent to K897188 (Espe GmbH (Us), 1990) and 1 other predicate after a 94-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Aug 21, 2008
- Review
- 94 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K897188 (1990). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K100510Ceramir Crown & BridgeDoxa AB · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K897188 | Ketac-Cem Maxicap | Espe GmbH (Us) | 1990 | — |
| 0 (this device) | K081405 | Xeracem | Doxa Dental AB | 2008 | — |
| +1 | K100510 | Ceramir Crown & Bridge | Doxa AB | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 EMA? 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 EMA device
- #1 K254109 G-Cem Universalscore 15.0 · 13 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 |
|---|---|---|---|
| * | K897188 | Ketac-Cem MaxicapSummary page 1…Predicate Devices Trade name 510(k) holder 510(k) No. Ketac T M Cem MaxicapT M ESPE GMBH K897188 DoxaDent"7-- Doxa Certex AB K01 1839 5.4. Intended Use/Indications for Use XeraCem is a hybrid… | 1990 |
| * | K011839 | Doxadent Dental Composite, Models a, B, C, 12A, 12B, 12C, 6A, 6B, and 6CSummary page 1…510(k) No. Ketac T M Cem MaxicapT M ESPE GMBH K897188 DoxaDent"7-- Doxa Certex AB K01 1839 5.4. Intended Use/Indications for Use XeraCem is a hybrid between glass ionomer cenent and ceramic cement based on calcium alum… | 2002 |
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 |
|---|---|---|---|
| K100510 | Ceramir Crown & Bridge | 2010 | 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?
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, 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 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
What is it indicated for?
XeraCem is intended for the permanent cementation of:
Porcelain Fused to Metal Crowns and Bridges
Metal (gold etc.) crowns and bridges
Gold inlays and onlays
Prefabricated metal and cast posts
Prefabricated metal provisional crowns
All-zirconia or all-alumina ceramic crowns and bridges
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081405 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081405: Xeracem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081405
Report an extraction error
Are you the manufacturer?
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