FDA product code DYX: Lock, Wire, And Ligature, Intraoral
DYX is the FDA product code for lock, wire, and ligature, intraoral. It is a Class II device, regulated under 21 CFR 872.4600 and reviewed by the Dental panel. FDA has cleared 11 510(k) submissions under DYX, from 11 different applicants. The average 510(k) review took 138 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Lock, Wire, And Ligature, Intraoral |
| Device class | Class II |
| Regulation | 21 CFR 872.4600 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for DYX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 260 |
Compare with all 510(k) review times · Search every DYX clearance
Top DYX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Summit Medical, Inc. | 1 | 2017-04-11 |
| KLS-Martin L.P. | 1 | 2006-06-30 |
| Casey Surgical, LLC | 1 | 2003-07-15 |
| Zygomatics , Ltd. | 1 | 2003-06-27 |
| Doctor'S Research Group, Inc. | 1 | 1999-09-14 |
6 more applicants have DYX clearances. See the full list in Caduvo.
Most recent DYX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162046 | Summit Medical, Inc. | MINNE TIES MMF Suture System | 2017-04-11 | 260 |
| K061271 | KLS-Martin L.P. | ERCH ARCH BAR, MODEL 38-690-00 | 2006-06-30 | 56 |
| K031207 | Casey Surgical, LLC | SAFETY RELEASE ARCH BAR KIT | 2003-07-15 | 90 |
| K030605 | Zygomatics , Ltd. | RAPID IMF | 2003-06-27 | 122 |
| K990212 | Doctor'S Research Group, Inc. | LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 | 1999-09-14 | 235 |
Recalls for DYX devices
openFDA lists no recalls for product code DYX.
Frequently asked questions
What is FDA product code DYX?
DYX is the FDA product code for lock, wire, and ligature, intraoral. It is a Class II device, regulated under 21 CFR 872.4600 and reviewed by the Dental panel.
What device class is DYX?
Class II, regulation 21 CFR 872.4600. Typical premarket route: 510(k).
How long does a 510(k) take for product code DYX?
Across 11 cleared submissions the average was 138 days from receipt to decision (median 90).
Which companies have the most DYX clearances?
Summit Medical, Inc. (1); KLS-Martin L.P. (1); Casey Surgical, LLC (1); Zygomatics , Ltd. (1); Doctor'S Research Group, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DYX
- Run a recall and safety report across every DYX manufacturer
- Watch product code DYX 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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