K201604 is an FDA 510(k) clearance for the Plasdent Disposable Barrier Sleeves and Barrier Film. This device is classified as a Dental Barriers And Sleeves (Class II - Special Controls, product code PEM).
Submitted by Plasdent Corporation (Pomona, US). The FDA issued a Cleared decision on December 23, 2020, 191 days after receiving the submission on June 15, 2020.
This device falls under the General & Plastic Surgery 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 | K201604 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2020 |
| Decision Date | December 23, 2020 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| 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. |