RODIN 3D Resin SPLINT, Hard/Flex (K231793) - FDA 510(k) Clearance

K231793 is an FDA 510(k) clearance for the RODIN 3D Resin SPLINT, Hard/Flex. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on March 26, 2024 after a review of 280 days - an extended review 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: 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 Belport Company, Inc., Gingi-Pak devices