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 |