Device manufacturer, as written on reports

Dentsply Implants A Division Of Dentsplu Ih: medical device reports filed with FDA

3,591 reports name it as the manufacturer of the device involved, 2020–2022.

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.

3,591
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 0%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

3,591 medical device reports received by FDA give Dentsply Implants A Division Of Dentsplu Ih as the manufacturer of the device involved, 0% of the MAUDE database, from December 2020 to January 2022. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

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%). 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
17-0543 Ank C/X Impl A9 5/D3 5/L9 5	Implant, endosseous, root-form	207	0	0%
17-0544 Ank C/X Impl A11/D3 5/L11	Implant, endosseous, root-form	207	0	0%
OsseoSpeed TX 3.5S - 11 mm	Implant, endosseous, root-form	76	769	0%
OsseoSpeed TX 4.0S - 9 mm	Implant, endosseous, root-form	66	877	0%
17-0543 Ank C/X Impl A9 5/D3 5/L9 5 Implants	Implant, endosseous, root-form	65	0	0%
OsseoSpeed TX 4.0S - 11 mm	Implant, endosseous, root-form	62	763	0%
OsseoSpeed EV 3.6 S - 11 mm	Implant, endosseous, root-form	61	531	0%
OsseoSpeed TX 3.5S - 9 mm	Implant, endosseous, root-form	61	687	0%
OsseoSpeed TX 4.5 - 11 mm	Implant, endosseous, root-form	56	539	0%
OsseoSpeed EV 4.2 S - 11 mm	Implant, endosseous, root-form	53	385	0%
OsseoSpeed TX 4.5 - 9 mm	Implant, endosseous, root-form	51	993	0%
OsseoSpeed EV 3.6 S - 9 mm	Implant, endosseous, root-form	50	419	0%
AstraTech Impl EV 3.6S 11mm OS	Implant, endosseous, root-form	43	933	0%
17-0544 Ank C/X Impl A11/D3 5/L11 Implants	Implant, endosseous, root-form	42	0	0%
OsseoSpeed TX 4.0S - 8 mm	Implant, endosseous, root-form	42	507	0%
17-0542 Ank C/X Impl A8/D3 5/L8 Implants	Implant, endosseous, root-form	33	0	0%
OsseoSpeed EV 4.2 S - 9 mm	Implant, endosseous, root-form	29	591	0%
OsseoSpeed TX 3.5S - 13 mm	Implant, endosseous, root-form	26	241	0%
OsseoSpeed TX 5.0 - 11 mm	Implant, endosseous, root-form	26	296	0%
OsseoSpeed TX 5.0 - 9 mm	Implant, endosseous, root-form	26	436	0%
17-0553 Ank C/X Impl B9 5/D4 5/L9 5 Implants	Implant, endosseous, root-form	20	0	0%
Osseospeed Tx 3 5s - 9 Mm Implants	Implant, endosseous, root-form	17	0	0%
600/38/11 Xive S Plus Impl D3 8/L11 Implants	Implant, endosseous, root-form	16	0	0%
Osseospeed Tx 3 5s - 11 Mm Implants	Implant, endosseous, root-form	10	0	0%
Osseospeed Ev 4 2 S - 11 Mm Implants	Implant, endosseous, root-form	9	0	0%
Osseospeed Tx 4 0s - 9 Mm Implants	Implant, endosseous, root-form	9	0	0%
Osseospeed Tx 4 0s - 11 Mm Implants	Implant, endosseous, root-form	8	0	0%
Osseospeed Ev 3 6 S - 11 Mm Implants	Implant, endosseous, root-form	7	0	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	3,591	100%

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

Death0%0

Injury100%3,591

Malfunction0%0

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 A Division Of Dentsplu Ih reports

How many FDA device reports name Dentsply Implants A Division Of Dentsplu Ih as manufacturer?

3,591 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

17-0543 Ank C/X Impl A9 5/D3 5/L9 5 (207), 17-0544 Ank C/X Impl A11/D3 5/L11 (207), OsseoSpeed TX 3.5S - 11 mm (76), OsseoSpeed TX 4.0S - 9 mm (66) and 17-0543 Ank C/X Impl A9 5/D3 5/L9 5 Implants (65).

Which device types does it report on?

implant, endosseous, root-form (100%).

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.