FDA Product Code
FDA Product Code PME — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3260
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K191133 | KATANA Cleaner, KATANA Cleaner (Trial) | Kuraray Noritake Dental, Inc. | 2019-10-08 | Traditional | PDF ↗ |
| K163171 | CeraClean | Bisco, Inc. | 2017-04-14 | Traditional | PDF ↗ |
| K152322 | Resolve 2.0 | Denali Corporation | 2015-12-16 | Traditional | PDF ↗ |
Product code PME · Class II · Dental. Data: openFDA.