Cleared Traditional

K260790 - G-Series Grind Guard

K260790 · ASESSO HEALTH, Inc. · Dental device
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Jun 2026
Decision
106d
Days
-
Risk

K260790 is an FDA 510(k) clearance for the G-Series Grind Guard. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by ASESSO HEALTH, Inc. (Pleasanton, US). The FDA issued a Cleared decision on June 25, 2026 after a review of 106 days - within the typical 510(k) review window.

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 ASESSO HEALTH, Inc. devices

FDA 510(k) Submission Details - K260790

510(k) Number K260790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2026
Decision Date June 25, 2026
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
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 20
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