PME
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- External Cleaning Solution
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3260
- Medical specialty
- Dental
- FDA definition
- For use on dental restorations, external to the mouth, prior to insertion into the mouth.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| KATANA Cleaner, KATANA Cleaner (Trial) (K191133) | Kuraray Noritake Dental, Inc. | 2019-10-08 |
| CeraClean (K163171) | Bisco, Inc. | 2017-04-14 |
| Resolve 2.0 (K152322) | Denali Corporation | 2015-12-16 |
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