els unibond— 510(k) K252151

Substantially Equivalent

Saremco Dental AG

FDA 510(k) clearance K252151 for els unibond, Substantially Equivalent on 2025-12-05. Applicant: Saremco Dental AG. Device class: 2.

Clearance details

Applicant: Saremco Dental AG
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2025-07-09
Decision date: 2025-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rebstein, CH

Download summary PDF View on FDA.gov ↗

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More clearances from Saremco Dental AG

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Data sourced from openFDA. This site is unofficial and independent of the FDA.