Cleared Traditional

SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE (K071404) - FDA 510(k) Clearance

K071404 · Power Products, Inc.-Splintek · Dental device
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Optimized for regulatory review, auditing and printing
Aug 2007
Decision
88d
Days
-
Risk

K071404 is an FDA 510(k) clearance for the SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Power Products, Inc.-Splintek (Lenexa, US). The FDA issued a Cleared decision on August 17, 2007 after a review of 88 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 Power Products, Inc.-Splintek devices

Submission Details

510(k) Number K071404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2007
Decision Date August 17, 2007
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
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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