Straumann® ProClean™ Cassette (041.800 ; 041.801)
FDA 510(k) clearance K260726 · decided 2026-06-03
Clearance details
- K-number
- K260726
- Device name
- Straumann® ProClean™ Cassette (041.800 ; 041.801)
- Applicant
- Institut Straumann AG
- Decision
- Substantially Equivalent
- Date received
- 2026-03-05
- Decision date
- 2026-06-03
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- KCT
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Basel, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.