DESS® Dental Smart Solutions
K-Number: K252384 · 2025-10-23
ApplicantTerrats Medical SL
Decision Date2025-10-23
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
DESS® Dental Smart Solutions is a medical device manufactured by Terrats Medical SL. It received FDA 510(k) clearance on 2025-10-23 under approval number K252384. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DESS® Dental Smart Solutions?
DESS® Dental Smart Solutions is a medical device that received FDA 510(k) clearance on 2025-10-23. It is manufactured by Terrats Medical SL. The 510(k) number is K252384.
When was DESS® Dental Smart Solutions approved by the FDA?
DESS® Dental Smart Solutions received FDA 510(k) clearance on 2025-10-23, under approval number K252384.
What company makes DESS® Dental Smart Solutions?
DESS® Dental Smart Solutions is manufactured by Terrats Medical SL.
What is the FDA product code for DESS® Dental Smart Solutions?
The FDA product code for DESS® Dental Smart Solutions is NHA.
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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.