Devices › Resin, root canal filling
Device brand name · Resin root canal filling
Realseal: medical device reports filed with FDA
269 reports name it, 2011–2018. Manufacturer given most often on reports: Sybronendo. Product code KIF.
- 269
- device reports naming the brand
- 0% of all MAUDE reports · about 18 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0%
- classified as malfunction
- 5.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
269 medical device reports received by FDA name the brand "Realseal" (resin root canal filling); the manufacturer given most often on reports is Sybronendo; received from September 2011 to November 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 resin, root canal filling reports (product code KIF) death is recorded in 0% and malfunction in 5.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device operates differently than expected (48%), insufficient device problem information (23.4%) and loss of or failure to bond (11.9%). The patient problems coded most often are pain, failure of implant and abscess. 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 Realseal was received in the five years to August 2026; the latest was received in November 2018.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 704 reports carrying product code KIF. 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 |
|---|---|---|---|
| Device operates differently than expectedthe device behaved unexpectedly | 129 | 48% | 18.2% |
| Insufficient device problem information | 63 | 23.4% | 32% |
| Loss of or failure to bond | 32 | 11.9% | 5% |
| Material disintegration | 32 | 11.9% | 4.5% |
| Material integrity problema problem with the device material | 18 | 6.7% | 3% |
| Failure to adhere or bond | 9 | 3.3% | 2.1% |
| Therapeutic or diagnostic output failure | 9 | 3.3% | 0% |
| Degraded | 3 | 1.1% | 0.4% |
| Breakthe device broke | 1 | 0.4% | 0.1% |
| Defective devicethe device was defective | 1 | 0.4% | 0% |
| Device contamination with chemical or other material | 1 | 0.4% | 0.4% |
| Loss of threshold | 1 | 0.4% | 0.1% |
| Material discolored | 1 | 0.4% | 0.9% |
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 |
|---|---|---|
| Painpain, site not specified | 71 | 26.4% |
| Failure of implant | 22 | 8.2% |
| Abscessa collection of pus | 20 | 7.4% |
| Complaint, ill-defined | 1 | 0.4% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.4% |
| Impaired healingslow healing | 1 | 0.4% |
| Malaisegeneral feeling of being unwell | 1 | 0.4% |
| Purulent discharge | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Realseal | Product code KIF | All MAUDE reports |
|---|---|---|---|
| Reports | 269 | 704 | 26,136,888 |
| Share of that pool | — | 38.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 100% | 93.5% | 36.2% |
| Classified as malfunction | 0% | 5.8% | 62.3% |
| Filed by the manufacturer | 100% | 96.4% | 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 KIF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Realseal Se | 250 | 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 Realseal reports
How many FDA reports name Realseal?
269 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?
device operates differently than expected (48%), insufficient device problem information (23.4%), loss of or failure to bond (11.9%), material disintegration (11.9%) and material integrity problem (6.7%). 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 Realseal 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.