Cleared Traditional

SprintRay Denture Base

K220979 · Sprintray, Inc. · Dental
Sep 2022
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K220979 is an FDA 510(k) clearance for the SprintRay Denture Base, 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 September 14, 2022, 163 days after receiving the submission on April 4, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K220979 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2022
Decision Date September 14, 2022
Days to Decision 163 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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