510(k) K163447
K163447 is an FDA 510(k) premarket notification submitted by Premium Plus International Limited for the device "Premium Plus Disposable Barrier Sleeve". The FDA issued a decision of Substantially Equivalent on June 20, 2017. The device falls under product code PEM (Dental Barriers And Sleeves), a Class II device regulated under 21 CFR 878.4370. Premium Plus International Limited has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2017
- Date Received
- December 8, 2016
- 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.