K201604 is an FDA 510(k) clearance for the Plasdent Disposable Barrier Sleeves and Barrier Film, 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 review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K201604 FDA.gov |
| FDA Decision | Cleared 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. |