510(k) K162311
K162311 is an FDA 510(k) premarket notification submitted by Institut Straumann AG for the device "Straumann PrefGel". The FDA issued a decision of Substantially Equivalent on March 7, 2017. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device. Institut Straumann AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 2017
- Date Received
- August 18, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleanser, Root Canal
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type