FDA product code PFL: Intraoral, Dental Foam Protector
PFL is the FDA product code for intraoral, dental foam protector. It is a Class I device, regulated under 21 CFR 872.6890 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under PFL. The average 510(k) review took 138 days (median 138).
Definition
Intended to provide a soft barrier between wired mouth hardware and oral mucosa.
Classification
| Field | Value |
|---|---|
| Device name | Intraoral, Dental Foam Protector |
| Device class | Class I |
| Regulation | 21 CFR 872.6890 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every PFL clearance
Top PFL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Elba Laboratories, Inc. | 1 | 2013-09-30 |
Most recent PFL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131396 | Elba Laboratories, Inc. | WIRED MOUTH PROTECTOR (WMP) | 2013-09-30 | 138 |
Recalls for PFL devices
openFDA lists no recalls for product code PFL.
Frequently asked questions
What is FDA product code PFL?
PFL is the FDA product code for intraoral, dental foam protector. It is a Class I device, regulated under 21 CFR 872.6890 and reviewed by the Dental panel.
What device class is PFL?
Class I, regulation 21 CFR 872.6890. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PFL?
Across 1 cleared submissions the average was 138 days from receipt to decision (median 138).
Which companies have the most PFL clearances?
Elba Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PFL
- Run a recall and safety report across every PFL manufacturer
- Watch product code PFL 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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