510(k) · Cleared
ClearedXceram
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xceramusa · EIH Powder, Porcelain
Cleared on Apr 8, 2010 as substantially equivalent to K070537 (Cdl Technologies, Inc., 2007) and 1 other predicate after a 71-day review. Its family tree reaches back 7 generations to 1983.
- Decided
- Apr 8, 2010
- Review
- 71 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K830955 (1983). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 6 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 5 generations backK984201 DenzirDentronic AB · 1999
- 4 generations backK023327 Cynovad ZirkonCynovad · 2002
- 3 generations backK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- 2 generations backK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- 1 generation backK092630 ZIROXZencera, Inc. · 2009
- This deviceK100250 XceramXceramusa · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −6 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −5 | K984201 | Denzir | Dentronic AB | 1999 | — |
| −4 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| −3 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| −2 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| −1 | K092630 | ZIROX | Zencera, Inc. | 2009 | — |
| 0 (this device) | K100250 | Xceram | Xceramusa | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1998 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070537 | ZirblockSummary page 1…orcelain, powder for clinical use CFR: 21 CFR 872.6660 Class: Class II medical device Product Code: ETH Panel: Dental Predicate devices: K070537 Zirelock®, CDL Technologies; 1(92513 Rainbow Block, enoss Co. Ltd.; K(092630 Zirox, Zencera, Inc. Device descriptio… | 2007 |
| Kept off the family tree | K092513 | FDA’s K092513 is Rainbow Block Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
| * | K092630 | ZIROXSummary page 1…cal device Product Code: ETH Panel: Dental Predicate devices: K070537 Zirelock®, CDL Technologies; 1(92513 Rainbow Block, enoss Co. Ltd.; K(092630 Zirox, Zencera, Inc. Device description: Xceram@ is a pre-formed material for use by dental laboratories in filling orders/presc… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- None of the 22 ancestors has a recall.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Used in the manufacture of dental prosthetics: crowns, bridges, inlays, and onlays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100250: Xceram.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100250
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