Devices › Device types
FDA product code DZE · class 2 · Dental
Implant, endosseous, root-form: medical device reports filed with FDA
3,924,241 reports carry this product code, 1993–2026; 30 brands with a page.
- 3,924,241
- reports with this product code
- 15% of all MAUDE reports
- 771,057
- reports, 12 months to August 2026
- 767,516 in the 12 months before
- 0.8%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code DZE is FDA's classification for "Implant, endosseous, root-form" (dental panel), a class 2 device. 3,924,241 medical device reports carry this product code, 15% of the MAUDE database, from January 1993 to August 2026.
771,057 reports arrived in the 12 months to August 2026, close to the 767,516 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 (99.2%) and malfunction (0.8%). 30 brand names 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
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 | 1,209,133 | 30.8% |
| Nobel Biocare | 899,040 | 22.9% |
| Nobel Biocare G Teborg | 488,700 | 12.5% |
| Jjgc | 234,276 | 6% |
| Dentsply Implants Manufacturing | 171,490 | 4.4% |
| Nobel Biocare USA | 143,331 | 3.7% |
| Mis Implants Technologies | 126,857 | 3.2% |
| Altatec | 90,984 | 2.3% |
| Dentsply Implants A Division Of Dentsply Ih | 82,828 | 2.1% |
| Anthogyr | 63,074 | 1.6% |
| Biohorizons Implant Systems | 58,036 | 1.5% |
| Biohorizons | 57,263 | 1.5% |
| Implant Direct Sybron Manufacturing | 31,807 | 0.8% |
| S I N Implant System | 29,415 | 0.7% |
| Neodent - Jjgc | 23,646 | 0.6% |
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 | 2,465,589 | 62.8% |
| Loss of osseointegration | 880,752 | 22.4% |
| Osseointegration problem | 300,481 | 7.7% |
| Fracturea broken bone | 63,553 | 1.6% |
| Difficult to insertthe device was hard to insert | 14,178 | 0.4% |
| Patient device interaction problem | 11,588 | 0.3% |
| Insufficient device problem information | 6,787 | 0.2% |
| Migrationthe device moved from where it was placed | 5,783 | 0.1% |
| Separation failure | 5,054 | 0.1% |
| Positioning failure | 4,288 | 0.1% |
| Malposition of device | 3,149 | 0.1% |
| Premature separation | 2,617 | 0.1% |
| Material deformation | 2,341 | 0.1% |
| Explanted | 2,147 | 0.1% |
| Positioning problem | 2,048 | 0.1% |
| Mechanical problema mechanical problem | 2,030 | 0.1% |
| Loosening of implant not related to bone-ingrowth | 1,978 | 0.1% |
| Unintended movement | 1,346 | 0% |
| Activation, positioning or separation problem | 1,284 | 0% |
| Device markings/labelling problema problem with the device markings or label | 1,232 | 0% |
Questions about implant, endosseous, root-form reports
What is product code DZE?
FDA's classification code for "Implant, endosseous, root-form", class 2, reviewed by the dental panel. Every device report carries the product code of the device involved.
How many reports carry this code?
3,924,241 reports through August 2026, 771,057 of them in the latest 12 months.
Which brands appear most often?
Biohorizons Dental Implant (58,732), BioHorizons Inc. (57,004), NobelActive Internal RP 4.3x10mm (49,098), BLT ?4.1mm RC, SLA? 10mm, TiZr, Loxim (45,650) and NobelParallel CC RP 4.3x10mm (44,269). 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.