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

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.

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