Cleared Traditional

K211158 - NTI ClenchGuard (FDA 510(k) Clearance)

K211158 · Boyd Research, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
151d
Days
-
Risk

K211158 is an FDA 510(k) clearance for the NTI ClenchGuard. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Boyd Research, Inc. (St Pete Beach, US). The FDA issued a Cleared decision on September 17, 2021 after a review of 151 days - an extended review cycle.

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 Boyd Research, Inc. devices

Submission Details

510(k) Number K211158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2021
Decision Date September 17, 2021
Days to Decision 151 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 127d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OBR Mouthguard, Over-the-counter
Device Class -
Definition To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding.

Regulatory Peers - OBR Mouthguard, Over-the-counter

All 44
Devices cleared under the same product code (OBR) and FDA review panel - the closest regulatory comparables to K211158.
ClenchNoMore (CNM-1 (Mixed sizing))
K252485 · 1987 Media Limited · Apr 2026
Owl Night Guard
K253641 · Owl Dental Lab, Inc. · Feb 2026
enCore Night Guard
K252004 · Encore Guards · Nov 2025
Remi Custom Night Guard
K251778 · Remi · Oct 2025
Dentemp Pro-Comfort Dental Guard
K250456 · Doc Brands, Inc. · May 2025
Anti Grinding Guard
K240810 · Xiamen Yizhou Imp. & Exp. Co., Ltd. · May 2024