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

FDA 510(k) Submission Details - K024261

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.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 63
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K024261.
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ACCU-BITE HOME KIT DISCLUDER
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NTI CLENCHING SUPPRESSION SYSTEM
K981546 · Heraeus Kulzer, Inc. · Jul 1998
NIGHTGUARD DIAGNOSTIC APPLIANCE
K955701 · Cycura Corp. · Mar 1996