Cleared Traditional

NOBILCAM IMPAK Disc

K251252 · Shandong Huge Dental Material Corporation · Dental
Aug 2025
Decision
100d
Days
—
Risk

About This 510(k) Submission

K251252 is an FDA 510(k) clearance for the NOBILCAM IMPAK Disc, a Mouthguard, Prescription, submitted by Shandong Huge Dental Material Corporation (Rizhao City, CN). The FDA issued a Cleared decision on August 1, 2025, 100 days after receiving the submission on April 23, 2025. This device falls under the Dental review panel.

Submission Details

510(k) Number K251252 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2025
Decision Date August 01, 2025
Days to Decision 100 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MQC — Mouthguard, Prescription
Device Class —