FDA product code DZI: Drill, Bone, Powered
DZI is the FDA product code for drill, bone, powered. It is a Class II device, regulated under 21 CFR 872.4120 and reviewed by the Dental panel. FDA has cleared 48 510(k) submissions under DZI, 4 in the last five years, from 29 different applicants. The average 510(k) review took 151 days (median 138); 42 days on average over the last three years. FDA has posted 20 recalls for DZI devices.
Classification
| Field | Value |
|---|---|
| Device name | Drill, Bone, Powered |
| 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 DZI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 3 | 277 |
| 2020 | 3 | 254 |
| 2023 | 1 | 121 |
| 2024 | 2 | 84 |
| 2025 | 1 | 1 |
Top DZI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mectron S.P.A. | 5 | 2024-08-19 |
| Jedmed Instrument Co. | 4 | 1981-01-28 |
| Satelec | 3 | 2009-12-11 |
| Nakanishi, Inc. | 2 | 2025-12-23 |
| Implant Direct Sybron Manufacturing, LLC | 2 | 2023-08-16 |
24 more applicants have DZI clearances. See the full list in Caduvo.
Most recent DZI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254163 | Nakanishi, Inc. | VarioSurg 4 | 2025-12-23 | 1 |
| K242432 | Mectron S.P.A. | MT-Bone | 2024-08-19 | 3 |
| K240340 | Guangdong Jinme Medical Technology Co., Ltd. | Surgical Drive System (Model: ES70, ES90, E8) | 2024-07-18 | 164 |
| K231087 | Implant Direct Sybron Manufacturing, LLC | Guided Surgery Kit | 2023-08-16 | 121 |
| K192561 | Saeshin Precision Co., Ltd. | TRAUS SUS20 | 2020-07-13 | 300 |
Recalls for DZI devices
20 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-03-14.
| Year | Recalls |
|---|---|
| 2019 | 13 |
Frequently asked questions
What is FDA product code DZI?
DZI is the FDA product code for drill, bone, powered. It is a Class II device, regulated under 21 CFR 872.4120 and reviewed by the Dental panel.
What device class is DZI?
Class II, regulation 21 CFR 872.4120. Typical premarket route: 510(k).
How long does a 510(k) take for product code DZI?
Across 48 cleared submissions the average was 151 days from receipt to decision (median 138).
Which companies have the most DZI clearances?
Mectron S.P.A. (5); Jedmed Instrument Co. (4); Satelec (3); Nakanishi, Inc. (2); Implant Direct Sybron Manufacturing, LLC (2).
Have DZI devices been recalled?
Yes: 20 product recalls across 4 recall events; the most recent began 2019-03-14.
Next steps
- Run an FDA pathway report with predicate devices for product code DZI
- Run a recall and safety report across every DZI manufacturer
- Watch product code DZI 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.