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FDA product code NHA · class 2 · Dental
Abutment, implant, dental, endosseous: medical device reports filed with FDA
8,582 reports carry this product code, 2003–2026; 30 brands with a page.
- 8,582
- reports with this product code
- 0% of all MAUDE reports
- 1,956
- reports, 12 months to August 2026
- 745 in the 12 months before
- 67.1%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code NHA is FDA's classification for "Abutment, implant, dental, endosseous" (dental panel), a class 2 device. 8,582 medical device reports carry this product code, 0% of the MAUDE database, from November 2003 to August 2026.
1,956 reports arrived in the 12 months to August 2026, up 163% from 745 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 malfunction (67.1%), injury (32.8%) and other (0.1%). 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 |
|---|---|---|
| Biomet 3i | 4,700 | 54.8% |
| Dentsply Implants Manufacturing | 847 | 9.9% |
| Zimmer Dental | 764 | 8.9% |
| Biohorizons Implant Systems | 390 | 4.5% |
| Zimvie US | 380 | 4.4% |
| Dentsply Implants A Division Of Dentsply Ih | 176 | 2.1% |
| Implant Direct Sybron Manufacturing | 167 | 1.9% |
| Mis Implants Technologies | 145 | 1.7% |
| Ace Surgical Supply | 144 | 1.7% |
| Zest Anchors | 93 | 1.1% |
| Keystone Dental | 64 | 0.7% |
| Biohorizons | 63 | 0.7% |
| Prismatik Dentalcraft | 43 | 0.5% |
| Z-Systems | 23 | 0.3% |
| Nobel Biocare USA | 19 | 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 |
|---|---|---|
| Fracturea broken bone | 5,710 | 66.5% |
| Unintended movement | 756 | 8.8% |
| Positioning failure | 427 | 5% |
| Mechanical problema mechanical problem | 307 | 3.6% |
| Failure to osseointegrate | 225 | 2.6% |
| Breakthe device broke | 177 | 2.1% |
| Separation failure | 175 | 2% |
| Migration or expulsion of device | 134 | 1.6% |
| Loose or intermittent connection | 72 | 0.8% |
| Failure to advance | 69 | 0.8% |
| Insufficient device problem information | 59 | 0.7% |
| Difficult to removethe device was hard to remove | 52 | 0.6% |
| Positioning problem | 52 | 0.6% |
| Loss of osseointegration | 47 | 0.5% |
| Separation problem | 46 | 0.5% |
| Connection problema connection problem | 40 | 0.5% |
| Patient device interaction problem | 36 | 0.4% |
| Nonstandard device | 35 | 0.4% |
| Damaged thread | 30 | 0.3% |
| Detachment of device or device componentpart of the device came off | 27 | 0.3% |
Questions about abutment, implant, dental, endosseous reports
What is product code NHA?
FDA's classification code for "Abutment, implant, dental, endosseous", class 2, reviewed by the dental panel. Every device report carries the product code of the device involved.
How many reports carry this code?
8,582 reports through August 2026, 1,956 of them in the latest 12 months.
Which brands appear most often?
Certain Gold-Tite Hexed Screw (1,361), Certain Titanium Hexed Screw (442), Titanium Hexed Uniscrew (346), Bellatek Zirconia Abutment (222) and Gold-Tite Square Uniscrew (213). 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.