Reported Reactions

Manufacturers

Device manufacturer, as written on reports

Dentsply Implants Manufacturing: medical device reports filed with FDA

172,869 reports name it as the manufacturer of the device involved, 2013–2026.

172,869
reports naming it as manufacturer
0.7% of all MAUDE reports
38,026
reports, 12 months to August 2026
36,675 in the 12 months before
0.5%
classified as malfunction
62.3% across all reports
0%
classified as death, as reported
0.9% across all reports

172,869 medical device reports received by FDA give Dentsply Implants Manufacturing as the manufacturer of the device involved, 0.7% of the MAUDE database, from January 2013 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

38,026 reports arrived in the 12 months to August 2026, close to the 36,675 of 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 (99.5%) and malfunction (0.5%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

BrandDevice typeReportsLatest 12 monthsClassified as death
ANK C/X Impl A9.5/D3.5/L9.5Implant, endosseous, root-form9,4971,7570%
ANK C/X Impl A11/D3.5/L11Implant, endosseous, root-form8,8961,6440%
ANK C/X Impl A8/D3.5/L8Implant, endosseous, root-form5,7791,1970%
OsseoSpeed TX 4.5 - 9 mmImplant, endosseous, root-form4,5109930%
AstraTech Impl EV 3.6S 11mm OSImplant, endosseous, root-form4,3799330%
OsseoSpeed TX 3.5S - 11 mmImplant, endosseous, root-form4,1367690%
OsseoSpeed TX 4.0S - 9 mmImplant, endosseous, root-form4,1248770%
ANK C/X Impl B9.5/D4.5/L9.5Implant, endosseous, root-form3,8037980%
OsseoSpeed TX 4.0S - 11 mmImplant, endosseous, root-form3,7987630%
XiVE S plus Impl D3.8/L11Implant, endosseous, root-form3,6195060%
ANK C/X Impl B8/D4.5/L8Implant, endosseous, root-form3,3177180%
OsseoSpeed TX 3.5S - 9 mmImplant, endosseous, root-form3,2926870%
AstraTech Impl EV 3.6S 9mm OSImplant, endosseous, root-form3,2027980%
OsseoSpeed TX 4.5 - 11 mmImplant, endosseous, root-form3,1375390%
AstraTech Impl EV 4.2S 11mm OSImplant, endosseous, root-form3,0646990%
AstraTech Impl EV 4.2S 9mm OSImplant, endosseous, root-form3,0448120%
XiVE S plus Impl D3.8/L9.5Implant, endosseous, root-form2,5233930%
ANK C/X Impl B11/D4.5/L11Implant, endosseous, root-form2,4215410%
OsseoSpeed TX 4.0S - 8 mmImplant, endosseous, root-form2,2995070%
OsseoSpeed TX 5.0 - 9 mmImplant, endosseous, root-form2,1624360%
ANK C/X Impl A14/D3.5/L14Implant, endosseous, root-form2,0274020%
XiVE S plus Impl D4.5/L9.5Implant, endosseous, root-form1,9743240%
AstraTech Impl EV 4.8S 9mm OSImplant, endosseous, root-form1,5164280%
OsseoSpeed EV 4.2 S - 9 mmImplant, endosseous, root-form1,4915910%
OsseoSpeed EV 3.6 S - 11 mmImplant, endosseous, root-form1,4675310%
XiVE S plus Impl D4.5/L11Implant, endosseous, root-form1,4502260%
XiVE S plus Impl D3.8/L8Implant, endosseous, root-form1,1712500%
XIVE S plus Impl D4,5/L8Implant, endosseous, root-form1,0442400%
XiVE S plus Impl D3.4/L11Implant, endosseous, root-form9522340%
OsseoSpeed EV 4.2 S - 11 mmImplant, endosseous, root-form8403850%

Brands with a page on this site, 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."

Device types

Product codeDevice typeReportsShare
DZEImplant, endosseous, root-form171,49099.2%
NHAAbutment, implant, dental, endosseous8470.5%
NDPAccessories, implant, dental, endosseous5420.3%
EJLBur, dental70%
EKSFile, pulp canal, endodontic20%
KMWHandpiece, rotary bone cutting10%
LLZSystem, image processing, radiological10%

Reports by month, five years

02,4964,991Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 2,486Apr 2022: 3,255May 2022: 3,361Jun 2022: 3,039Jul 2022: 2,502Aug 2022: 3,062Sep 2022: 2,237Oct 2022: 2,587Nov 2022: 3,043Dec 2022: 2,9842023Jan 2023: 3,203Feb 2023: 3,369Mar 2023: 2,941Apr 2023: 3,129May 2023: 3,238Jun 2023: 3,124Jul 2023: 3,207Aug 2023: 3,445Sep 2023: 2,599Oct 2023: 3,075Nov 2023: 2,913Dec 2023: 2,1762024Jan 2024: 3,741Feb 2024: 3,446Mar 2024: 2,981Apr 2024: 3,454May 2024: 3,171Jun 2024: 3,381Jul 2024: 3,292Aug 2024: 3,911Sep 2024: 3,205Oct 2024: 3,391Nov 2024: 2,565Dec 2024: 1,9122025Jan 2025: 3,035Feb 2025: 2,262Mar 2025: 4,991Apr 2025: 1,595May 2025: 2,082Jun 2025: 3,240Jul 2025: 4,572Aug 2025: 3,825Sep 2025: 3,221Oct 2025: 2,582Nov 2025: 2,496Dec 2025: 3,0352026Jan 2026: 4,417Feb 2026: 3,016Mar 2026: 3,129Apr 2026: 4,135May 2026: 2,234Jun 2026: 3,351Jul 2026: 4,193Aug 2026: 2,217

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

Event type

Death0%0
Injury99.5%171,979
Malfunction0.5%890
Other0%0
Not given0%0

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Dentsply Implants Manufacturing reports

How many FDA device reports name Dentsply Implants Manufacturing as manufacturer?

172,869 reports through August 2026, 38,026 of them in the latest 12 months.

Which of its brands appear most often?

ANK C/X Impl A9.5/D3.5/L9.5 (9,497), ANK C/X Impl A11/D3.5/L11 (8,896), ANK C/X Impl A8/D3.5/L8 (5,779), OsseoSpeed TX 4.5 - 9 mm (4,510) and AstraTech Impl EV 3.6S 11mm OS (4,379).

Which device types does it report on?

implant, endosseous, root-form (99.2%), abutment, implant, dental, endosseous (0.5%), accessories, implant, dental, endosseous (0.3%) and bur, dental (0%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.