Cleared Traditional

GRIND GUARD (K090472) - FDA 510(k) Clearance

K090472 · Archtek, Inc. · Dental device
Download Printable Device Report (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.

View all Archtek, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 127d · This submission: 232d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 70
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