Cleared Traditional

K211158 - NTI ClenchGuard

K211158 · Boyd Research, Inc. · Dental device
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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

FDA 510(k) Submission Details - K211158

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.

OBR Device Classification - Class 0,

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 19
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