FDA product code PME: External Cleaning Solution
PME is the FDA product code for external cleaning solution. It is a Class II device, regulated under 21 CFR 872.3260 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under PME, from 3 different applicants. The average 510(k) review took 145 days (median 151).
Definition
For use on dental restorations, external to the mouth, prior to insertion into the mouth.
Classification
| Field | Value |
|---|---|
| Device name | External Cleaning Solution |
| Device class | Class II |
| Regulation | 21 CFR 872.3260 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
510(k) clearances per year for PME
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 151 |
| 2019 | 1 | 162 |
Compare with all 510(k) review times · Search every PME clearance
Top PME applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kuraray Noritake Dental, Inc. | 1 | 2019-10-08 |
| Bisco, Inc. | 1 | 2017-04-14 |
| Denali Corporation | 1 | 2015-12-16 |
Most recent PME clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191133 | Kuraray Noritake Dental, Inc. | KATANA Cleaner, KATANA Cleaner (Trial) | 2019-10-08 | 162 |
| K163171 | Bisco, Inc. | CeraClean | 2017-04-14 | 151 |
| K152322 | Denali Corporation | Resolve 2.0 | 2015-12-16 | 121 |
Recalls for PME devices
openFDA lists no recalls for product code PME.
Frequently asked questions
What is FDA product code PME?
PME is the FDA product code for external cleaning solution. It is a Class II device, regulated under 21 CFR 872.3260 and reviewed by the Dental panel.
What device class is PME?
Class II, regulation 21 CFR 872.3260. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PME?
Across 3 cleared submissions the average was 145 days from receipt to decision (median 151).
Which companies have the most PME clearances?
Kuraray Noritake Dental, Inc. (1); Bisco, Inc. (1); Denali Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PME
- Run a recall and safety report across every PME manufacturer
- Watch product code PME 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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