Device brand name · Resin tooth bonding agent

Optibond Xtr: medical device reports filed with FDA

247 reports name it, 2012–2015. Manufacturer given most often on reports: Kerr. Product code KLE.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

247
device reports naming the brand: 0% of all MAUDE reports · about 17 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 0%
classified as malfunction: 2.6% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 247 reports that name the brand "Optibond Xtr" (resin tooth bonding agent), received between April 2012 and December 2015; the manufacturer given most often on reports is Kerr. Spellings of one product vary from report to report.

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 agent, tooth bonding, resin reports (product code KLE) death is recorded in 0% and malfunction in 2.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are insufficient device problem information (33.2%), loss of or failure to bond (22.7%) and patient-device incompatibility (17.4%). The patient problems coded most often are hypersensitivity/allergic reaction, sensitivity of teeth and failure of implant. 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 Optibond Xtr was received in the five years to August 2026; the latest was received in December 2015.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury100%247

Malfunction0%0

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%247

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 1,159 reports carrying product code KLE. 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
Insufficient device problem information	82	33.2%	15.4%
Loss of or failure to bond	56	22.7%	18.8%
Patient-device incompatibilitythe device did not suit the patient	43	17.4%	12.5%
Failure to adhere or bond	25	10.1%	8.3%
Device operates differently than expectedthe device behaved unexpectedly	11	4.5%	2.7%
Detachment of device component	5	2%	1.6%
Breakthe device broke	1	0.4%	0.5%
Component falling	1	0.4%	0.3%
Device or device fragments location unknown	1	0.4%	0%

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
Hypersensitivity/allergic reaction	65	26.3%
Sensitivity of teeth	65	26.3%
Failure of implant	9	3.6%
Increased sensitivity	4	1.6%
Painpain, site not specified	2	0.8%
Therapeutic response, increased	2	0.8%
Tooth fracture	2	0.8%
Complaint, ill-defined	1	0.4%
Reactiona reaction, type not specified	1	0.4%
Respiratory distressdifficulty breathing	1	0.4%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Optibond Xtr	Product code KLE	All MAUDE reports
Reports	247	1,159	26,136,888
Share of that pool	—	21.3%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	100%	93.5%	36.2%
Classified as malfunction	0%	2.6%	62.3%
Filed by the manufacturer	100%	94%	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."

Questions about Optibond Xtr reports

How many FDA reports name Optibond Xtr?

247 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?

insufficient device problem information (33.2%), loss of or failure to bond (22.7%), patient-device incompatibility (17.4%), failure to adhere or bond (10.1%) and device operates differently than expected (4.5%). 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 Optibond Xtr 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.