FDA product code LFE: Solution, Cold Sterilizing
LFE is the FDA product code for solution, cold sterilizing. It is a Class II device, regulated under 21 CFR 880.6885 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under LFE. The average 510(k) review took 55 days (median 55).
Classification
| Field | Value |
|---|---|
| Device name | Solution, Cold Sterilizing |
| Device class | Class II |
| Regulation | 21 CFR 880.6885 |
| Review panel | DE — Dental |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LFE clearance
Top LFE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| North Pacific Dental, Inc. | 1 | 1983-03-07 |
Most recent LFE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830106 | North Pacific Dental, Inc. | UNICIDE | 1983-03-07 | 55 |
Recalls for LFE devices
openFDA lists no recalls for product code LFE.
Frequently asked questions
What is FDA product code LFE?
LFE is the FDA product code for solution, cold sterilizing. It is a Class II device, regulated under 21 CFR 880.6885 and reviewed by the Dental panel.
What device class is LFE?
Class II, regulation 21 CFR 880.6885. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFE?
Across 1 cleared submissions the average was 55 days from receipt to decision (median 55).
Which companies have the most LFE clearances?
North Pacific Dental, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LFE
- Run a recall and safety report across every LFE manufacturer
- Watch product code LFE 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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