Cleared Traditional

Crown HT

K242277 · Sprintray, Inc. · Dental
Oct 2024
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K242277 is an FDA 510(k) clearance for the Crown HT, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Sprintray, Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 1, 2024, 61 days after receiving the submission on August 1, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K242277 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2024
Decision Date October 01, 2024
Days to Decision 61 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690