The following data is part of a premarket notification filed by Premium Plus (dongguan) Limited with the FDA for Disposable Barrier Sleeves.
| Device ID | K220662 |
| 510k Number | K220662 |
| Device Name: | Disposable Barrier Sleeves |
| Classification | Dental Barriers And Sleeves |
| Applicant | Premium Plus (Dongguan) Limited No.1 Industrial Area, Tutang, Changping Dongguan, CN 523581 |
| Contact | Jessica Mao |
| Correspondent | Jessica Mao Premium Plus (Dongguan) Limited No.1 Industrial Area, Tutang, Changping Dongguan, CN 523581 |
| Product Code | PEM |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-07 |
| Decision Date | 2022-05-11 |