File, pulp canal, endodontic: medical device reports filed with FDA

3,963 reports carry this product code, 1996–2026; 7 brands with a page.

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.

3,963
reports with this product code: 0% of all MAUDE reports; 381
reports, 12 months to August 2026: 307 in the 12 months before; 94.4%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code EKS is FDA's classification for "File, pulp canal, endodontic" (dental panel), a class 1 device. 3,963 medical device reports carry this product code, 0% of the MAUDE database, from August 1996 to August 2026.

381 reports arrived in the 12 months to August 2026, up 24% from 307 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 malfunction (94.4%), injury (5.5%) and other (0.1%). 7 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Reciproc Blue Files 6x Sterile	522	42	0%	98.3%
Profile Gt Rotary Instrument	412	0	0%	95.2%
Reciproc Files 6x	307	20	0%	95.8%
Waveone Gold Reciprocating File Primary 25mm	163	9	0%	96.9%
Protaper Nt Rotary File	102	0	0%	91.2%
PrimeTaper EV 4.2 x 9mm OS	1	519	0%	0.3%
Unknown ATIS implant	1	183	0%	0.2%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Tulsa Dental Products	662	16.7%
Vdw	623	15.7%
Dentsply Tulsa	588	14.8%
Dentsply Vdw	556	14%
Maillefer Instruments Holding Sarl	546	13.8%
Dentsply Maillefer	420	10.6%
Dentsply Implants Manufacturing	2	0.1%
Dentsply	1	0%
Dentsply Implants A Division Of Dentsply Ih	1	0%
Kerr	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0%0

Injury5.5%218

Malfunction94.4%3,740

Other0.1%3

Not given0.1%2

Who filed

Manufacturer report99.6%3,948

Voluntary report0.2%6

User facility report0%0

Distributor report0.2%8

Not given0%1

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	3,081	77.7%
Material separation	892	22.5%
Device, or device fragments remain in patient	256	6.5%
Difficult to removethe device was hard to remove	108	2.7%
Entrapment of device	62	1.6%
Detachment of device or device componentpart of the device came off	40	1%
Detachment of device component	18	0.5%
Material fragmentation	14	0.4%
Fracturea broken bone	12	0.3%
Device or device fragments location unknown	11	0.3%
Device, removal of (non-implant)	11	0.3%
Tip breakage	9	0.2%
Component falling	5	0.1%
Device operates differently than expectedthe device behaved unexpectedly	5	0.1%
Device remains implanted	5	0.1%
Insufficient device problem information	5	0.1%
Material integrity problema problem with the device material	5	0.1%
Material split, cut or torn	5	0.1%
Device handling problem	3	0.1%
Failure to reset	3	0.1%

Questions about file, pulp canal, endodontic reports

What is product code EKS?

FDA's classification code for "File, pulp canal, endodontic", class 1, reviewed by the dental panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,963 reports through August 2026, 381 of them in the latest 12 months.

Which brands appear most often?

Reciproc Blue Files 6x Sterile (522), Profile Gt Rotary Instrument (412), Reciproc Files 6x (307), Waveone Gold Reciprocating File Primary 25mm (163) and Protaper Nt Rotary File (102). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.