510(k) K220662
K220662 is an FDA 510(k) premarket notification submitted by Premium Plus (Dongguan) Limited for the device "Disposable Barrier Sleeves". The FDA issued a decision of Substantially Equivalent on May 11, 2022. The device falls under product code PEM (Dental Barriers And Sleeves), a Class II device regulated under 21 CFR 878.4370. Premium Plus (Dongguan) Limited has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 2022
- Date Received
- March 7, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dental Barriers And Sleeves
- Device Class
- Class II
- Regulation Number
- 878.4370
- Review Panel
- DE
- Submission Type
Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.