Cleared Traditional

Apex Flex

K250617 · Sprintray, Inc. · Dental
Apr 2025
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K250617 is an FDA 510(k) clearance for the Apex Flex, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Sprintray, Inc. (Los Angeles, US). The FDA issued a Cleared decision on April 29, 2025, 60 days after receiving the submission on February 28, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K250617 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2025
Decision Date April 29, 2025
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

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