Cleared Traditional

K090472 - GRIND GUARD

K090472 · Archtek, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
232d
Days
-
Risk

K090472 is an FDA 510(k) clearance for the GRIND GUARD. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Archtek, Inc. (Austin, US). The FDA issued a Cleared decision on October 14, 2009 after a review of 232 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.

FDA 510(k) Submission Details - K090472

510(k) Number K090472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2009
Decision Date October 14, 2009
Days to Decision 232 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 128d · This submission: 232d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 71
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K090472 · GRIND GUARD
Download PDF FDA Summary Archtek, Inc.