Cleared Traditional

K121272 - PROTECH DENT

K121272 · Akervall Technologies, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
171d
Days
-
Risk

K121272 is an FDA 510(k) clearance for the PROTECH DENT. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Akervall Technologies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on October 15, 2012 after a review of 171 days - an extended review 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: 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 - K121272

510(k) Number K121272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2012
Decision Date October 15, 2012
Days to Decision 171 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
43d slower than avg
Panel avg: 128d · This submission: 171d
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
Devices cleared under the same product code (OBR) and FDA review panel - the closest regulatory comparables to K121272.
GRINDGUARD
K133037 · Grind Guard Technologies, LLC · Jan 2014
REST ASSURED EXTRA COMFORT NITE PROTECTOR
K133423 · Ranir, LLC · Dec 2013
NEW COMFORT-FIT DENTAL GUARD
K123849 · Den Tek Oral Care, Inc. · Jan 2013
ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD
K113326 · Oralabs, Inc. · Jun 2012
REST ASSURED GENERATION III DENTAL PROTECTOR
K120103 · Ranir, LLC · Feb 2012
REST ASSURED READY TO WEAR NITE PROTECTOR
K112879 · Ranir, LLC · Jan 2012
K121272 · PROTECH DENT
Download PDF FDA Summary Akervall Technologies…