K052271 is an FDA 510(k) clearance for the RINSENDO. This device is classified as a Handpiece, Air-powered, Root Canal Irrigation (Class I - General Controls, product code NYL).
Submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on May 26, 2006, 280 days after receiving the submission on August 19, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200. To Clean The Root Canal Prior To Filling And Used For Root Canal Irrigation..
| 510(k) Number | K052271 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2005 |
| Decision Date | May 26, 2006 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | NYL - Handpiece, Air-powered, Root Canal Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |
| Definition | To Clean The Root Canal Prior To Filling And Used For Root Canal Irrigation. |