FDA 510(k) clearance · back to tracker

Elos Accurate® Denture Fixation System

Elos Medtech Pinol A/S cleared K253774 on 2026-05-20, decision: substantially equivalent

K-number

K253774

Sponsor

Elos Medtech Pinol A/S

Device

Elos Accurate® Denture Fixation System

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-20

Product code

NHA

Advisory committee

Dental

Medical specialty

Dental

Regulation number

872.3630

Official FDA record

Open K253774on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.