K191133 is an FDA 510(k) clearance for the KATANA Cleaner, KATANA Cleaner (Trial). This device is classified as a External Cleaning Solution (Class II - Special Controls, product code PME).
Submitted by Kuraray Noritake Dental, Inc. (Chiyoda-Ku, JP). The FDA issued a Cleared decision on October 8, 2019, 162 days after receiving the submission on April 29, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260. For Use On Dental Restorations, External To The Mouth, Prior To Insertion Into The Mouth..
| 510(k) Number | K191133 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2019 |
| Decision Date | October 08, 2019 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | PME — External Cleaning Solution |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3260 |
| Definition | For Use On Dental Restorations, External To The Mouth, Prior To Insertion Into The Mouth. |