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Device brand name · Material tooth shade resin
Lava Ultimate Cad/Cam Restorative For Cerec: medical device reports filed with FDA
168 reports name it, 2015–2018. Manufacturer given most often on reports: 3m Espe Dental Products. Product code EBF.
- 168
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0%
- classified as malfunction
- 2.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
168 medical device reports received by FDA name the brand "Lava Ultimate Cad/Cam Restorative For Cerec" (material tooth shade resin); the manufacturer given most often on reports is 3m Espe Dental Products; received from April 2015 to May 2018. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (100%); across all material, tooth shade, resin reports (product code EBF) death is recorded in 0.1% and malfunction in 2.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are nonstandard device (3%), patient-device incompatibility (3%) and insufficient device problem information (1.8%). The patient problems coded most often are sensitivity of teeth, pain and complaint, ill-defined. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Lava Ultimate Cad/Cam Restorative For Cerec was received in the five years to August 2026; the latest was received in May 2018.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 961 reports carrying product code EBF. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Nonstandard device | 5 | 3% | 1.1% |
| Patient-device incompatibilitythe device did not suit the patient | 5 | 3% | 6.6% |
| Insufficient device problem information | 3 | 1.8% | 6.9% |
| Failure to adhere or bond | 2 | 1.2% | 2.7% |
| Migration or expulsion of device | 2 | 1.2% | 0.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.6% | 9.4% |
| Loss of or failure to bond | 1 | 0.6% | 4.7% |
| Material integrity problema problem with the device material | 1 | 0.6% | 6.1% |
| Missing value reason | 1 | 0.6% | 0.6% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Sensitivity of teeth | 5 | 3% |
| Painpain, site not specified | 2 | 1.2% |
| Complaint, ill-defined | 1 | 0.6% |
| Discomfortdiscomfort | 1 | 0.6% |
| Hypersensitivity/allergic reaction | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Lava Ultimate Cad/Cam Restorative For Cerec | Product code EBF | All MAUDE reports |
|---|---|---|---|
| Reports | 168 | 961 | 26,136,888 |
| Share of that pool | — | 17.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 100% | 96.1% | 36.2% |
| Classified as malfunction | 0% | 2.2% | 62.3% |
| Filed by the manufacturer | 100% | 94.2% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code EBF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Sonicfill Composite | 262 | 0 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Lava Ultimate Cad/Cam Restorative For Cerec reports
How many FDA reports name Lava Ultimate Cad/Cam Restorative For Cerec?
168 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
nonstandard device (3%), patient-device incompatibility (3%), insufficient device problem information (1.8%), failure to adhere or bond (1.2%) and migration or expulsion of device (1.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Lava Ultimate Cad/Cam Restorative For Cerec was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.