FDA product code DZJ: Driver, Wire, And Bone Drill, Manual
DZJ is the FDA product code for driver, wire, and bone drill, manual. It is a Class II device, regulated under 21 CFR 872.4120 and reviewed by the Dental panel. FDA has cleared 32 510(k) submissions under DZJ, 9 in the last five years, from 26 different applicants. The average 510(k) review took 184 days (median 137); 74 days on average over the last three years. FDA has posted 11 recalls for DZJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Driver, Wire, And Bone Drill, Manual |
| Device class | Class II |
| Regulation | 21 CFR 872.4120 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DZJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 154 |
| 2019 | 1 | 161 |
| 2020 | 4 | 414 |
| 2021 | 3 | 350 |
| 2022 | 3 | 190 |
| 2023 | 3 | 144 |
| 2024 | 1 | 132 |
| 2025 | 1 | 88 |
| 2026 | 1 | 2 |
Compare with all 510(k) review times · Search every DZJ clearance
Top DZJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medcad | 2 | 2023-03-07 |
| 3D Systems | 2 | 2021-04-26 |
| KLS-Martin L.P. | 2 | 2019-03-11 |
| Propel Orthodontics, LLC | 2 | 2018-01-17 |
| Medical Modeling, Inc. | 2 | 2014-01-22 |
21 more applicants have DZJ clearances. See the full list in Caduvo.
Most recent DZJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261826 | 3D Systems, Inc. | VSP System (Titanium Palatal Splint) | 2026-06-03 | 2 |
| K243637 | Materialise NV | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | 2025-02-21 | 88 |
| K242263 | Techfit Digital Surgery, Inc. | TECHFIT DISRP® System | 2024-12-11 | 132 |
| K231520 | Techmah Cmf | tmCMF Solution | 2023-10-02 | 130 |
| K230276 | Techfit Digital Surgery | TECHFIT DISRP® System | 2023-06-23 | 142 |
Recalls for DZJ devices
11 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-17.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code DZJ?
DZJ is the FDA product code for driver, wire, and bone drill, manual. It is a Class II device, regulated under 21 CFR 872.4120 and reviewed by the Dental panel.
What device class is DZJ?
Class II, regulation 21 CFR 872.4120. Typical premarket route: 510(k).
How long does a 510(k) take for product code DZJ?
Across 32 cleared submissions the average was 184 days from receipt to decision (median 137).
Which companies have the most DZJ clearances?
Medcad (2); 3D Systems (2); KLS-Martin L.P. (2); Propel Orthodontics, LLC (2); Medical Modeling, Inc. (2).
Have DZJ devices been recalled?
Yes: 11 product recalls across 5 recall events; the most recent began 2022-05-17.
Next steps
- Run an FDA pathway report with predicate devices for product code DZJ
- Run a recall and safety report across every DZJ manufacturer
- Watch product code DZJ 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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