K232087 - Dental LT Comfort Resin (FDA 510(k) Clearance)

K232087 is an FDA 510(k) clearance for the Dental LT Comfort Resin. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Formlabs Ohio, Inc. (Millbury, US). The FDA issued a Cleared decision on February 16, 2024 after a review of 218 days - an extended review cycle.

This device falls under the Dental FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Formlabs Ohio, Inc. devices