K253798 - UltraPrint-Dental Hard Splint UV (FDA 510(k) Clearance)

K253798 is an FDA 510(k) clearance for the UltraPrint-Dental Hard Splint UV. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Guangzhou Heygears IMC., Inc. (Guangzhou, CN). The FDA issued a Cleared decision on March 2, 2026 after a review of 94 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 Guangzhou Heygears IMC., Inc. devices