510(k) K151123
K151123 is an FDA 510(k) premarket notification submitted by Pac-Dent International, Inc. for the device "Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film". The FDA issued a decision of Substantially Equivalent on March 3, 2016. The device falls under product code PEM (Dental Barriers And Sleeves), a Class II device regulated under 21 CFR 878.4370. Pac-Dent International, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 3, 2016
- Date Received
- April 28, 2015
- 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.