NOBILCAM IMPAK Disc— 510(k) K251252

Name: FDA 510(k) clearance K251252
Creator: U.S. Food and Drug Administration
Published: 2025-08-01

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. Device class: Unclassified.

Clearance details

Applicant: Shandong Huge Dental Material Corporation
Product code: Code MQC
Device class: Unclassified
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 ↗

Recent devices under product code MQC

view all

K253798 — UltraPrint-Dental Hard Splint UV2026-03-02
K250743 — Remvia NightGuard2025-12-05
K241729 — Hard Splint & Thermo-Adaptive Splint2025-03-18
K243516 — Remi Custom Night Guard2025-02-10
K241369 — LIJIA Night Guard2024-08-22

More clearances from Shandong Huge Dental Material Corporation

view all

K260376 — Denture Base2026-05-06
K260067 — Eternal Art Porcelain Powders2026-04-09
K220680 — Denture Base Polymers2022-08-12
K213994 — Flexible Block2022-03-04
K201684 — A-Silicone for Bite Registration2020-09-24

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.