Cleared Traditional

MOUTHGUARD AND ALIGNER MATERIALS (K062828) - FDA 510(k) Clearance

K062828 · Dentsply Intl., Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Nov 2006
Decision
68d
Days
-
Risk

K062828 is an FDA 510(k) clearance for the MOUTHGUARD AND ALIGNER MATERIALS. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Dentsply Intl., Inc. (York, US). The FDA issued a Cleared decision on November 27, 2006 after a review of 68 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 Dentsply Intl., Inc. devices

Submission Details

510(k) Number K062828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2006
Decision Date November 27, 2006
Days to Decision 68 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
59d faster than avg
Panel avg: 127d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -