Cleared Special

K073220 - THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT

K073220 · Prestige Brands, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
34d
Days
-
Risk

K073220 is an FDA 510(k) clearance for the THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Prestige Brands, Inc. (Irvington, US). The FDA issued a Cleared decision on December 19, 2007 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Prestige Brands, Inc. devices

FDA 510(k) Submission Details - K073220

510(k) Number K073220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2007
Decision Date December 19, 2007
Days to Decision 34 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 127d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

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.