Device manufacturer, as written on reports

S I N Implant System: medical device reports filed with FDA

29,415 reports name it as the manufacturer of the device involved, 2024–2026.

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.

29,415
reports naming it as manufacturer: 0.1% of all MAUDE reports; 6,597
reports, 12 months to August 2026: 22,327 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

29,415 medical device reports received by FDA give S I N Implant System as the manufacturer of the device involved, 0.1% of the MAUDE database, from June 2024 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

6,597 reports arrived in the 12 months to August 2026, down 70% from 22,327 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
Dental Implant STRONG SW	Implant, endosseous, root-form	10,389	1,202	0%
Dental Implant EPIKUT	Implant, endosseous, root-form	5,802	2,118	0%
Dental Implant EPIKUT PLUS	Implant, endosseous, root-form	2,546	996	0%
Dental Implant STRONG SW PLUS	Implant, endosseous, root-form	2,456	278	0%
Dental Implant UNITITE PRIME	Implant, endosseous, root-form	2,016	129	0%
Dental Implant STRONG SWC	Implant, endosseous, root-form	1,960	582	0%
Dental Implant Tryon Cy	Implant, endosseous, root-form	1,168	0	0%
Dental Implant UNITITE COMPACT	Implant, endosseous, root-form	756	165	0%
Dental Implant EPIKUT S	Implant, endosseous, root-form	584	418	0%
Dental Implant EPIKUT S PLUS	Implant, endosseous, root-form	536	344	0%
Dental Implant UNITITE SLIM	Implant, endosseous, root-form	520	106	0%
Dental Implant Tryon Co	Implant, endosseous, root-form	209	0	0%
Dental Implant VERSALIS S	Implant, endosseous, root-form	173	173	0%
Dental Implant	Implant, endosseous, root-form	1	29	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	29,415	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%29,415

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 S I N Implant System reports

How many FDA device reports name S I N Implant System as manufacturer?

29,415 reports through August 2026, 6,597 of them in the latest 12 months.

Which of its brands appear most often?

Dental Implant STRONG SW (10,389), Dental Implant EPIKUT (5,802), Dental Implant EPIKUT PLUS (2,546), Dental Implant STRONG SW PLUS (2,456) and Dental Implant UNITITE PRIME (2,016).

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.