Cleared Traditional

Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece (K222845) - FDA 510(k) Clearance

K222845 · Frey Oral Technologies, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
433d
Days
-
Risk

K222845 is an FDA 510(k) clearance for the Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Frey Oral Technologies, LLC (Beverly Hills, US). The FDA issued a Cleared decision on November 28, 2023 after a review of 433 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Frey Oral Technologies, LLC devices

Submission Details

510(k) Number K222845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2022
Decision Date November 28, 2023
Days to Decision 433 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
306d slower than avg
Panel avg: 127d · This submission: 433d
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 K222845.
Dental LT Comfort Resin
K232087 · Formlabs Ohio, Inc. · Feb 2024
Myoaligner Appliance
K230548 · Myohealth Technologies, LLC · Feb 2024
LuxCreo Dental Night Guard Resin
K230592 · LuxCreo, Inc. · Jan 2024
Serena Sleep Night Guard
K230495 · Meris Investment Group · Oct 2023
FREEPRINT® splintmaster
K232448 · Detax GmbH · Oct 2023
Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)
K230237 · Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. · Sep 2023