510(k) K191448
K191448 is an FDA 510(k) premarket notification submitted by Ivoclar Vivadent, AG for the device "Barrier Sleeves". The FDA issued a decision of Substantially Equivalent on October 8, 2019. The device falls under product code PEM (Dental Barriers And Sleeves), a Class II device regulated under 21 CFR 878.4370. Ivoclar Vivadent, AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2019
- Date Received
- May 31, 2019
- 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.