Cleared Traditional

LuxCreo Dental Night Guard Resin

K230592 · LuxCreo, Inc. · Dental
Jan 2024
Decision
321d
Days
—
Risk

About This 510(k) Submission

K230592 is an FDA 510(k) clearance for the LuxCreo Dental Night Guard Resin, a Mouthguard, Prescription, submitted by LuxCreo, Inc. (Belmont, US). The FDA issued a Cleared decision on January 18, 2024, 321 days after receiving the submission on March 3, 2023. This device falls under the Dental review panel.

Submission Details

510(k) Number K230592 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2023
Decision Date January 18, 2024
Days to Decision 321 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code MQC — Mouthguard, Prescription
Device Class —