els unibond
K-Number: K252151 · 2025-12-05
ApplicantSaremco Dental AG
Decision Date2025-12-05
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
els unibond is a medical device manufactured by Saremco Dental AG. It received FDA 510(k) clearance on 2025-12-05 under approval number K252151. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the els unibond?
els unibond is a medical device that received FDA 510(k) clearance on 2025-12-05. It is manufactured by Saremco Dental AG. The 510(k) number is K252151.
When was els unibond approved by the FDA?
els unibond received FDA 510(k) clearance on 2025-12-05, under approval number K252151.
What company makes els unibond?
els unibond is manufactured by Saremco Dental AG.
What is the FDA product code for els unibond?
The FDA product code for els unibond is KLE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.