K220662 is an FDA 510(k) clearance for the Disposable Barrier Sleeves. This device is classified as a Dental Barriers And Sleeves (Class II - Special Controls, product code PEM).
Submitted by Premium Plus (Dongguan) Limited (Dongguan, CN). The FDA issued a Cleared decision on May 11, 2022, 65 days after receiving the submission on March 7, 2022.
This device falls under the Dental 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 | K220662 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2022 |
| Decision Date | May 11, 2022 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| 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. |