Cleared Traditional

K202974 - DenTek Fresh Protect Dental Guard (FDA 510(k) Clearance)

K202974 · Medtech Products, Inc. · Dental device
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Dec 2020
Decision
83d
Days
-
Risk

K202974 is an FDA 510(k) clearance for the DenTek Fresh Protect Dental Guard. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Medtech Products, Inc. (Tarrytown, US). The FDA issued a Cleared decision on December 22, 2020 after a review of 83 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 Medtech Products, Inc. devices

Submission Details

510(k) Number K202974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2020
Decision Date December 22, 2020
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

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