Profisil Free— 510(k) K262243
Substantially EquivalentKettenbach GmbH & Co. KG
FDA 510(k) clearance K262243 for Profisil Free, Substantially Equivalent on 2026-09-03. Applicant: Kettenbach GmbH & Co. KG. Device class: 2.
Summary
Profisil Free from Kettenbach is filed under LBH, cavity varnishes. The record doesn't give its composition or say what "Free" refers to.
Class II, 21 CFR 872.3260. Dental is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Kettenbach filed from Eschenburg, Germany. Review took 64 calendar days (July 1 to September 3, 2026).
Clearance details
- Applicant
- Kettenbach GmbH & Co. KG
- Product code
- Product code LBH
- Device class
- Class 2
- Regulation
- 21 CFR 872.3260
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eschenburg, DE
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Data sourced from openFDA. This site is unofficial and independent of the FDA.