Cleared Traditional

K022809 - EZ SPLINT & EZ SPLINT PM

K022809 · Power Products, Inc.-Splintek · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
420d
Days
-
Risk

K022809 is an FDA 510(k) clearance for the EZ SPLINT & EZ SPLINT PM. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Power Products, Inc.-Splintek (Great Neck, US). The FDA issued a Cleared decision on October 17, 2003 after a review of 420 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K022809

510(k) Number K022809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2002
Decision Date October 17, 2003
Days to Decision 420 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
292d slower than avg
Panel avg: 128d · This submission: 420d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 71
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K022809.
MOUTHGUARD AND ALIGNER MATERIALS
K062828 · Dentsply Intl., Inc. · Nov 2006
DOCTOR'S NIGHTGUARD
K053580 · Dental Concepts, LLC · Mar 2006
MYOHEALTH CLENCHING INHIBITOR
K040315 · Mci-Myohealth Systems · Aug 2004
PRIMOSPLINT SYSTEM
K030832 · Cosmedent, Inc. · Sep 2003
DENTAL PROTECTOR
K024261 · Dental Concepts, LLC · Mar 2003
DSG RELAXER SPLINT
K022627 · Sentage Corporation D/B/A/ Dental Services Group · Mar 2003
K022809 · EZ SPLINT & EZ SPLINT PM
Download PDF FDA Summary Power Products, Inc.-…