FDA product code DZK: Wire, Fixation, Intraosseous
DZK is the FDA product code for wire, fixation, intraosseous. It is a Class II device, regulated under 21 CFR 872.4880 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under DZK, from 2 different applicants. The average 510(k) review took 154 days (median 154).
Classification
| Field | Value |
|---|---|
| Device name | Wire, Fixation, Intraosseous |
| Device class | Class II |
| Regulation | 21 CFR 872.4880 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every DZK clearance
Top DZK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Russell B. Walther | 1 | 2010-04-02 |
| Ideatrics, Inc. | 1 | 2002-11-15 |
Most recent DZK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K092530 | Russell B. Walther | SPRYTIE, MODELS ST001, ST002 AND ST003 | 2010-04-02 | 227 |
| K022821 | Ideatrics, Inc. | ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E | 2002-11-15 | 81 |
Recalls for DZK devices
openFDA lists no recalls for product code DZK.
Frequently asked questions
What is FDA product code DZK?
DZK is the FDA product code for wire, fixation, intraosseous. It is a Class II device, regulated under 21 CFR 872.4880 and reviewed by the Dental panel.
What device class is DZK?
Class II, regulation 21 CFR 872.4880. Typical premarket route: 510(k).
How long does a 510(k) take for product code DZK?
Across 2 cleared submissions the average was 154 days from receipt to decision (median 154).
Which companies have the most DZK clearances?
Russell B. Walther (1); Ideatrics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DZK
- Run a recall and safety report across every DZK manufacturer
- Watch product code DZK 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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