FDA product code MXF: System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
MXF is the FDA product code for system, dental, hydrokinetic, caries removal & cavity preparation. It is a Class II device, regulated under 21 CFR 872.4120 and reviewed by the Dental panel. FDA has cleared 5 510(k) submissions under MXF, from 2 different applicants. The average 510(k) review took 102 days (median 78).
Classification
| Field | Value |
|---|---|
| Device name | System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation |
| 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 MXF clearance
Top MXF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biolase Technology, Inc. | 4 | 2003-02-03 |
| Endo Technic Corp. | 1 | 1999-05-27 |
Most recent MXF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022803 | Biolase Technology, Inc. | WATERLASE FOR APICOECTOMY | 2003-02-03 | 164 |
| K013908 | Biolase Technology, Inc. | WATERLASE MILLENNIUM | 2002-02-12 | 78 |
| K012511 | Biolase Technology, Inc. | WATERLASE MILLENNIUM | 2002-01-18 | 165 |
| K990908 | Endo Technic Corp. | MILLENNIUM | 1999-05-27 | 70 |
| K990219 | Biolase Technology, Inc. | MODIFICATION OF MILLENNIUM | 1999-02-24 | 33 |
Recalls for MXF devices
openFDA lists no recalls for product code MXF.
Frequently asked questions
What is FDA product code MXF?
MXF is the FDA product code for system, dental, hydrokinetic, caries removal & cavity preparation. It is a Class II device, regulated under 21 CFR 872.4120 and reviewed by the Dental panel.
What device class is MXF?
Class II, regulation 21 CFR 872.4120. Typical premarket route: 510(k).
How long does a 510(k) take for product code MXF?
Across 5 cleared submissions the average was 102 days from receipt to decision (median 78).
Which companies have the most MXF clearances?
Biolase Technology, Inc. (4); Endo Technic Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MXF
- Run a recall and safety report across every MXF manufacturer
- Watch product code MXF 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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