FDA product code DZH: Saw, Bone, Ac-Powered
DZH is the FDA product code for saw, bone, ac-powered. It is a Class II device, regulated under 21 CFR 872.4120 and reviewed by the Dental panel. FDA has cleared 4 510(k) submissions under DZH, from 3 different applicants. The average 510(k) review took 124 days (median 86).
Classification
| Field | Value |
|---|---|
| Device name | Saw, Bone, Ac-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 |
Compare with all 510(k) review times · Search every DZH clearance
Top DZH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Safety Equipment Corp. | 2 | 1976-11-16 |
| Dentatus USA , Ltd. | 1 | 2003-11-13 |
| Osada Electric Co., Ltd. | 1 | 1994-09-20 |
Most recent DZH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K031793 | Dentatus USA , Ltd. | DENTATUS OSCIOMAT | 2003-11-13 | 156 |
| K935443 | Osada Electric Co., Ltd. | ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS | 1994-09-20 | 312 |
| K760958 | American Safety Equipment Corp. | SURGICAL OSCILLATING SAW | 1976-11-16 | 15 |
| K760957 | American Safety Equipment Corp. | SURGICAL RECIPROCATING SAW | 1976-11-15 | 14 |
Recalls for DZH devices
openFDA lists no recalls for product code DZH.
Frequently asked questions
What is FDA product code DZH?
DZH is the FDA product code for saw, bone, ac-powered. It is a Class II device, regulated under 21 CFR 872.4120 and reviewed by the Dental panel.
What device class is DZH?
Class II, regulation 21 CFR 872.4120. Typical premarket route: 510(k).
How long does a 510(k) take for product code DZH?
Across 4 cleared submissions the average was 124 days from receipt to decision (median 86).
Which companies have the most DZH clearances?
American Safety Equipment Corp. (2); Dentatus USA , Ltd. (1); Osada Electric Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DZH
- Run a recall and safety report across every DZH manufacturer
- Watch product code DZH 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.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times