Cleared Traditional

K014079 - DR. HAYS BITE GUARD

K014079 · Inventive Resources, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
73d
Days
-
Risk

K014079 is an FDA 510(k) clearance for the DR. HAYS BITE GUARD. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Inventive Resources, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on February 22, 2002 after a review of 73 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 Inventive Resources, Inc. devices

FDA 510(k) Submission Details - K014079

510(k) Number K014079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2001
Decision Date February 22, 2002
Days to Decision 73 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
54d faster than avg
Panel avg: 127d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 56
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K014079.
FREEWAY COMFORT BITE GUARD
K110468 · Randmark Dental Products, LLC · Aug 2011
THERMOFORM SHEET MATERIALS AND ACCESSORIES
K072522 · Dentsply International, Inc. · Nov 2007
PRIMOSPLINT SYSTEM
K030832 · Cosmedent, Inc. · Sep 2003
ACCU-BITE HOME KIT DISCLUDER
K980953 · Jerome M. Simon · Oct 1998
NTI CLENCHING SUPPRESSION SYSTEM
K981546 · Heraeus Kulzer, Inc. · Jul 1998
NIGHTGUARD DIAGNOSTIC APPLIANCE
K955701 · Cycura Corp. · Mar 1996