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
| Brand | Device type | Reports | Latest 12 months | Classified as death |
|---|---|---|---|---|
| ANK C/X Impl A9.5/D3.5/L9.5 | Implant, endosseous, root-form | 9,497 | 1,757 | 0% |
| ANK C/X Impl A11/D3.5/L11 | Implant, endosseous, root-form | 8,896 | 1,644 | 0% |
| ANK C/X Impl A8/D3.5/L8 | Implant, endosseous, root-form | 5,779 | 1,197 | 0% |
| OsseoSpeed TX 4.5 - 9 mm | Implant, endosseous, root-form | 4,510 | 993 | 0% |
| AstraTech Impl EV 3.6S 11mm OS | Implant, endosseous, root-form | 4,379 | 933 | 0% |
| OsseoSpeed TX 3.5S - 11 mm | Implant, endosseous, root-form | 4,136 | 769 | 0% |
| OsseoSpeed TX 4.0S - 9 mm | Implant, endosseous, root-form | 4,124 | 877 | 0% |
| ANK C/X Impl B9.5/D4.5/L9.5 | Implant, endosseous, root-form | 3,803 | 798 | 0% |
| OsseoSpeed TX 4.0S - 11 mm | Implant, endosseous, root-form | 3,798 | 763 | 0% |
| XiVE S plus Impl D3.8/L11 | Implant, endosseous, root-form | 3,619 | 506 | 0% |
| ANK C/X Impl B8/D4.5/L8 | Implant, endosseous, root-form | 3,317 | 718 | 0% |
| OsseoSpeed TX 3.5S - 9 mm | Implant, endosseous, root-form | 3,292 | 687 | 0% |
| AstraTech Impl EV 3.6S 9mm OS | Implant, endosseous, root-form | 3,202 | 798 | 0% |
| OsseoSpeed TX 4.5 - 11 mm | Implant, endosseous, root-form | 3,137 | 539 | 0% |
| AstraTech Impl EV 4.2S 11mm OS | Implant, endosseous, root-form | 3,064 | 699 | 0% |
| AstraTech Impl EV 4.2S 9mm OS | Implant, endosseous, root-form | 3,044 | 812 | 0% |
| XiVE S plus Impl D3.8/L9.5 | Implant, endosseous, root-form | 2,523 | 393 | 0% |
| ANK C/X Impl B11/D4.5/L11 | Implant, endosseous, root-form | 2,421 | 541 | 0% |
| OsseoSpeed TX 4.0S - 8 mm | Implant, endosseous, root-form | 2,299 | 507 | 0% |
| OsseoSpeed TX 5.0 - 9 mm | Implant, endosseous, root-form | 2,162 | 436 | 0% |
| ANK C/X Impl A14/D3.5/L14 | Implant, endosseous, root-form | 2,027 | 402 | 0% |
| XiVE S plus Impl D4.5/L9.5 | Implant, endosseous, root-form | 1,974 | 324 | 0% |
| AstraTech Impl EV 4.8S 9mm OS | Implant, endosseous, root-form | 1,516 | 428 | 0% |
| OsseoSpeed EV 4.2 S - 9 mm | Implant, endosseous, root-form | 1,491 | 591 | 0% |
| OsseoSpeed EV 3.6 S - 11 mm | Implant, endosseous, root-form | 1,467 | 531 | 0% |
| XiVE S plus Impl D4.5/L11 | Implant, endosseous, root-form | 1,450 | 226 | 0% |
| XiVE S plus Impl D3.8/L8 | Implant, endosseous, root-form | 1,171 | 250 | 0% |
| XIVE S plus Impl D4,5/L8 | Implant, endosseous, root-form | 1,044 | 240 | 0% |
| XiVE S plus Impl D3.4/L11 | Implant, endosseous, root-form | 952 | 234 | 0% |
| OsseoSpeed EV 4.2 S - 11 mm | Implant, endosseous, root-form | 840 | 385 | 0% |
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 code | Device type | Reports | Share |
|---|---|---|---|
| DZE | Implant, endosseous, root-form | 171,490 | 99.2% |
| NHA | Abutment, implant, dental, endosseous | 847 | 0.5% |
| NDP | Accessories, implant, dental, endosseous | 542 | 0.3% |
| EJL | Bur, dental | 7 | 0% |
| EKS | File, pulp canal, endodontic | 2 | 0% |
| KMW | Handpiece, rotary bone cutting | 1 | 0% |
| LLZ | System, image processing, radiological | 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
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.