Cleared Traditional

OnX Tough

K230445 · Sprintray, Inc. · Dental
Jul 2023
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K230445 is an FDA 510(k) clearance for the OnX Tough, 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 July 14, 2023, 143 days after receiving the submission on February 21, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K230445 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2023
Decision Date July 14, 2023
Days to Decision 143 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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