Cleared Traditional

ClenchGuard (K181005) - FDA 510(k) Clearance

K181005 · Boyd Research, Inc. · Dental device
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Jan 2020
Decision
639d
Days
-
Risk

K181005 is an FDA 510(k) clearance for the ClenchGuard. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Boyd Research, Inc. (Solana Beach, US). The FDA issued a Cleared decision on January 15, 2020 after a review of 639 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 Boyd Research, Inc. devices

Submission Details

510(k) Number K181005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2018
Decision Date January 15, 2020
Days to Decision 639 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
512d slower than avg
Panel avg: 127d · This submission: 639d
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
Devices cleared under the same product code (OBR) and FDA review panel - the closest regulatory comparables to K181005.
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CustMBite Dental Guard
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K181099 · Koncept Innovators, LLC · Jan 2019