510(k) K111724
K111724 is an FDA 510(k) premarket notification submitted by Straumann USA for the device "STRAUMANN TIBRUSH". The FDA issued a decision of Substantially Equivalent on September 12, 2011. The device falls under product code ELB (Scaler, Rotary), a Class II device regulated under 21 CFR 872.4840. Straumann USA has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2011
- Date Received
- June 20, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Rotary
- Device Class
- Class II
- Regulation Number
- 872.4840
- Review Panel
- DE
- Submission Type