NOBILCAM IMPAK Disc— 510(k) K251252

Substantially Equivalent

Shandong Huge Dental Material Corporation

FDA 510(k) clearance K251252 for NOBILCAM IMPAK Disc, Substantially Equivalent on 2025-08-01. Applicant: Shandong Huge Dental Material Corporation.

Clearance details

Applicant: Shandong Huge Dental Material Corporation
Product code: Code MQC
Advisory panel: Unknown
Date received: 2025-04-23
Decision date: 2025-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rizhao City, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.