Cleared Traditional

DR. HAYS BITE GUARD (K014079) - FDA 510(k) Clearance

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

Submission Details

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.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -