Cleared Special

K073220 - THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT

K073220 · Prestige Brands, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 128d · 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.

Regulatory Peers - OBR Mouthguard, Over-the-counter

All 46
Devices cleared under the same product code (OBR) and FDA review panel - the closest regulatory comparables to K073220.
IMPROVED COMFORT-FIT NIGHTGUARD
K081669 · Den Tek Oral Care, Inc. · Jul 2008
STRESSGARD NIGHTGUARD
K072968 · Totalgard Corporation · Jul 2008
GRIND GUARD
K073446 · Archtek, Inc. · Feb 2008
DEN TEK COMFORT FIT NIGHTGUARD
K072147 · Den Tek Oral Care, Inc. · Aug 2007
REST ASSURED NITE PROTECTOR
K063229 · Ranir, LLC · Dec 2006
K073220 · THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT
Download PDF FDA Summary Prestige Brands, Inc.