Cleared Traditional

K024261 - DENTAL PROTECTOR

K024261 · Dental Concepts, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
93d
Days
-
Risk

K024261 is an FDA 510(k) clearance for the DENTAL PROTECTOR. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Dental Concepts, LLC (North Attleboro, US). The FDA issued a Cleared decision on March 26, 2003 after a review of 93 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.

View all Dental Concepts, LLC devices

Submission Details

510(k) Number K024261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2002
Decision Date March 26, 2003
Days to Decision 93 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
34d faster than avg
Panel avg: 127d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -