K163171 is an FDA 510(k) clearance for the CeraClean. This device is classified as a External Cleaning Solution (Class II - Special Controls, product code PME).
Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on April 14, 2017, 151 days after receiving the submission on November 14, 2016.
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 | K163171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2016 |
| Decision Date | April 14, 2017 |
| Days to Decision | 151 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. |