K241311 - Thermoforming Sheet Materials (Track A) (FDA 510(k) Clearance)

K241311 is an FDA 510(k) clearance for the Thermoforming Sheet Materials (Track A). Classified as Mouthguard, Prescription (product code MQC).

Submitted by Bernhard F?rster GmbH (Pforzheim, DE). The FDA issued a Cleared decision on August 2, 2024 after a review of 85 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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