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FDA product code OAT · class 2 · Dental
Implant, endosseous, orthodontic: medical device reports filed with FDA
430 reports carry this product code, 2007–2026; 1 brands with a page.
- 430
- reports with this product code
- 0% of all MAUDE reports
- 38
- reports, 12 months to August 2026
- 46 in the 12 months before
- 3.5%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code OAT is FDA's classification for "Implant, endosseous, orthodontic" (dental panel), a class 2 device. 430 medical device reports carry this product code, 0% of the MAUDE database, from December 2007 to August 2026.
38 reports arrived in the 12 months to August 2026, down 17% from 46 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 (96.3%), malfunction (3.5%) and other (0.2%). 1 brand name 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 |
|---|---|---|---|---|
| Palatal Implant ?4.1, L 4.2mm | 292 | 19 | 0% | 0% |
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 |
|---|---|---|
| Institut Straumann | 325 | 75.6% |
| Jjgc | 49 | 11.4% |
| Synthes Elmira | 5 | 1.2% |
| Biomet Microfixation | 1 | 0.2% |
| Prismatik Dentalcraft | 1 | 0.2% |
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
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Failure to osseointegrate | 333 | 77.4% |
| Loose or intermittent connection | 25 | 5.8% |
| Unintended movement | 17 | 4% |
| Breakthe device broke | 16 | 3.7% |
| Loss of osseointegration | 15 | 3.5% |
| Fracturea broken bone | 13 | 3% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 1.2% |
| Bent | 3 | 0.7% |
| Detachment of device or device componentpart of the device came off | 2 | 0.5% |
| Insufficient device problem information | 2 | 0.5% |
| Loose | 2 | 0.5% |
| Patient-device incompatibilitythe device did not suit the patient | 2 | 0.5% |
| Compatibility problem | 1 | 0.2% |
| Detachment of device component | 1 | 0.2% |
| Device dislodged or dislocated | 1 | 0.2% |
| Device slipped | 1 | 0.2% |
| Difficult to insertthe device was hard to insert | 1 | 0.2% |
| Dislodged | 1 | 0.2% |
| Explanted | 1 | 0.2% |
| Failure to adhere or bond | 1 | 0.2% |
Questions about implant, endosseous, orthodontic reports
What is product code OAT?
FDA's classification code for "Implant, endosseous, orthodontic", class 2, reviewed by the dental panel. Every device report carries the product code of the device involved.
How many reports carry this code?
430 reports through August 2026, 38 of them in the latest 12 months.
Which brands appear most often?
Palatal Implant ?4.1, L 4.2mm (292). 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.