Cleared Traditional

K073446 - GRIND GUARD

K073446 · Archtek, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
63d
Days
-
Risk

K073446 is an FDA 510(k) clearance for the GRIND GUARD. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Archtek, Inc. (Austin, US). The FDA issued a Cleared decision on February 8, 2008 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Archtek, Inc. devices

FDA 510(k) Submission Details - K073446

510(k) Number K073446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2007
Decision Date February 08, 2008
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 127d · This submission: 63d
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.