510(k) K262243
K262243 is an FDA 510(k) premarket notification submitted by Kettenbach GmbH & Co. KG for the device "Profisil Free". The FDA issued a decision of Substantially Equivalent on September 3, 2026. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Kettenbach GmbH & Co. KG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 2026
- Date Received
- July 1, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Varnish, Cavity
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type