Cleared Traditional

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

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

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 19
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ClenchGuard
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