K160232 is an FDA 510(k) clearance for the Disposable Barrier Sleeves and Covers. This device is classified as a Dental Barriers And Sleeves (Class II - Special Controls, product code PEM).
Submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on June 7, 2016, 127 days after receiving the submission on February 1, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 878.4370. Intended To Serve As A Disposable Barrier For Dental Instruments To Reduce The Risk Of Cross Contamination Between Dental Patients..
| 510(k) Number | K160232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2016 |
| Decision Date | June 07, 2016 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | PEM — Dental Barriers And Sleeves |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |
| Definition | Intended To Serve As A Disposable Barrier For Dental Instruments To Reduce The Risk Of Cross Contamination Between Dental Patients. |