The following data is part of a premarket notification filed by Plasdent Corporation with the FDA for Plasdent Disposable Barrier Sleeves And Barrier Film.
| Device ID | K201604 |
| 510k Number | K201604 |
| Device Name: | Plasdent Disposable Barrier Sleeves And Barrier Film |
| Classification | Dental Barriers And Sleeves |
| Applicant | Plasdent Corporation 969 Price Street Pomona, CA 91767 |
| Contact | Belen G Walayat |
| Correspondent | Belen G Walayat Plasdent Corporation 969 Price Street Pomona, CA 91767 |
| Product Code | PEM |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-15 |
| Decision Date | 2020-12-23 |