K222061 - Dental LT Clear V2 Resin (FDA 510(k) Clearance)

K222061 is an FDA 510(k) clearance for the Dental LT Clear V2 Resin. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Formlabs Ohio, Inc. (Millbury, US). The FDA issued a Cleared decision on November 10, 2022 after a review of 120 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 Formlabs Ohio, Inc. devices