510(k) K260726
K260726 is an FDA 510(k) premarket notification submitted by Institut Straumann AG for the device "Straumann® ProClean Cassette (041.800 ; 041.801)". The FDA issued a decision of Substantially Equivalent on June 3, 2026. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Institut Straumann AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2026
- Date Received
- March 5, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type