Cleared Traditional

SprintRay High Impact Denture Base

K221678 · Sprintray, Inc. · Dental
Nov 2022
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K221678 is an FDA 510(k) clearance for the SprintRay High Impact 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 November 10, 2022, 154 days after receiving the submission on June 9, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K221678 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2022
Decision Date November 10, 2022
Days to Decision 154 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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