Cleared Traditional

NightGuard Flex

K212448 · Sprintray, Inc. · Dental
Nov 2021
Decision
99d
Days
—
Risk

About This 510(k) Submission

K212448 is an FDA 510(k) clearance for the NightGuard Flex, a Mouthguard, Prescription, submitted by Sprintray, Inc. (Los Angeles, US). The FDA issued a Cleared decision on November 12, 2021, 99 days after receiving the submission on August 5, 2021. This device falls under the Dental review panel.

Submission Details

510(k) Number K212448 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2021
Decision Date November 12, 2021
Days to Decision 99 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MQC — Mouthguard, Prescription
Device Class —