Cleared Traditional

RODIN 3D Resin SPLINT, Hard/Flex

K231793 · Belport Company, Inc., Gingi-Pak · Dental
Mar 2024
Decision
280d
Days
—
Risk

About This 510(k) Submission

K231793 is an FDA 510(k) clearance for the RODIN 3D Resin SPLINT, Hard/Flex, a Mouthguard, Prescription, submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on March 26, 2024, 280 days after receiving the submission on June 20, 2023. This device falls under the Dental review panel.

Submission Details

510(k) Number K231793 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2023
Decision Date March 26, 2024
Days to Decision 280 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code MQC — Mouthguard, Prescription
Device Class —