Cleared Traditional

K100545 - SLEEPRIGHT

K100545 · Power Products, Inc.-Splintek · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
98d
Days
-
Risk

K100545 is an FDA 510(k) clearance for the SLEEPRIGHT. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Power Products, Inc.-Splintek (Lenexa, US). The FDA issued a Cleared decision on June 4, 2010 after a review of 98 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K100545

510(k) Number K100545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2010
Decision Date June 04, 2010
Days to Decision 98 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
30d faster than avg
Panel avg: 128d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

OBR Device Classification - Class 0,

Product Code OBR Mouthguard, Over-the-counter
Device Class -
Definition To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding.

Regulatory Peers - OBR Mouthguard, Over-the-counter

All 46
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K100545 · SLEEPRIGHT
Download PDF FDA Summary Power Products, Inc.-…