Cleared Traditional

NightGuard Flex (K212448) - FDA 510(k) Clearance

K212448 · Sprintray, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2021
Decision
99d
Days
-
Risk

K212448 is an FDA 510(k) clearance for the NightGuard Flex. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Sprintray, Inc. (Los Angeles, US). The FDA issued a Cleared decision on November 12, 2021 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Sprintray, Inc. devices

Submission Details

510(k) Number K212448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 127d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 40
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K212448.
Thermeo System
K212017 · Pro3dure Medical GmbH · Apr 2022
Glidewell Appliance Resin, Hard/Soft
K214102 · Prismatik Dentalcraft, Inc. · Feb 2022
SleepRight Select-Comfort Dental Guard
K212767 · Splintek, Inc. · Dec 2021
GR Splint Resin System
K211415 · Pro3dure Medical GmbH · Oct 2021
LuxaPrint Ortho Plus
K210940 · Dmg Digital Enterprises SE · Sep 2021
JS Dental Lab Mouth Guard
K210011 · Ampower Dental Laboratories, LLC · Jul 2021