FDA product code DZE: Implant, Endosseous, Root-Form
DZE is the FDA product code for implant, endosseous, root-form. It is a Class II device, regulated under 21 CFR 872.3640 and reviewed by the Dental panel. FDA has cleared 1,549 510(k) submissions under DZE, 154 in the last five years, from 451 different applicants. The average 510(k) review took 203 days (median 156); 224 days on average over the last three years. 2 PMA applications cite this product code. FDA has posted 212 recalls for DZE devices, 13 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Implant, Endosseous, Root-Form |
| Device class | Class II |
| Regulation | 21 CFR 872.3640 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for DZE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 48 | 229 |
| 2018 | 41 | 235 |
| 2019 | 31 | 259 |
| 2020 | 41 | 266 |
| 2021 | 34 | 206 |
| 2022 | 34 | 274 |
| 2023 | 35 | 259 |
| 2024 | 40 | 230 |
| 2025 | 31 | 198 |
| 2026 | 14 | 245 |
Compare with all 510(k) review times · Search every DZE clearance
Top DZE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nobelpharma USA, Inc. | 51 | 1996-09-06 |
| Steri-Oss, Inc. | 40 | 1998-03-16 |
| Implant Innovations, Inc. | 37 | 2007-06-01 |
| Minimatic Implant Technology | 34 | 1992-01-15 |
| Institut Straumann AG | 30 | 2026-03-10 |
446 more applicants have DZE clearances. See the full list in Caduvo.
Most recent DZE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261392 | Paragon Implant Mfg., LLC | TriActive Dental Implant System | 2026-09-17 | 141 |
| K260463 | Zeros Co., Ltd. | ZEROS Dental Implant System | 2026-08-19 | 188 |
| K251188 | Uniqa Dental, Ltd. | UNIQA® Dental Implants System | 2026-06-25 | 434 |
| K251232 | Megagen Implant Co., Ltd. | MegaGen Zygoma Dental Implant System | 2026-06-18 | 422 |
| K250806 | A.B. Dental Devices , Ltd. | Dental Implant System | 2026-06-18 | 458 |
Recalls for DZE devices
212 product recalls in 110 recall events; 13 initiated in the last five years and 12 still open. Most recent: 2026-08-12.
| Year | Recalls |
|---|---|
| 2017 | 15 |
| 2018 | 10 |
| 2019 | 15 |
| 2020 | 1 |
| 2021 | 6 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 4 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code DZE?
DZE is the FDA product code for implant, endosseous, root-form. It is a Class II device, regulated under 21 CFR 872.3640 and reviewed by the Dental panel.
What device class is DZE?
Class II, regulation 21 CFR 872.3640. Typical premarket route: 510(k).
How long does a 510(k) take for product code DZE?
Across 1,549 cleared submissions the average was 203 days from receipt to decision (median 156).
Which companies have the most DZE clearances?
Nobelpharma USA, Inc. (51); Steri-Oss, Inc. (40); Implant Innovations, Inc. (37); Minimatic Implant Technology (34); Institut Straumann AG (30).
Have DZE devices been recalled?
Yes: 212 product recalls across 110 recall events; the most recent began 2026-08-12.
Next steps
- Run an FDA pathway report with predicate devices for product code DZE
- Run a recall and safety report across every DZE manufacturer
- Watch product code DZE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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