Cleared Traditional

K082723 - GRINDGUARD

K082723 · Grind Guard Technologies, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
348d
Days
-
Risk

K082723 is an FDA 510(k) clearance for the GRINDGUARD. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Grind Guard Technologies, LLC (Leola, US). The FDA issued a Cleared decision on August 31, 2009 after a review of 348 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K082723

510(k) Number K082723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2008
Decision Date August 31, 2009
Days to Decision 348 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
220d slower than avg
Panel avg: 128d · This submission: 348d
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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K082723 · GRINDGUARD
Download PDF FDA Summary Grind Guard Technolog…