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FDA 510(k)

NOBILCAM IMPAK Disc

K-Number: K251252 · 2025-08-01

ApplicantShandong Huge Dental Material Corporation
Decision Date2025-08-01
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

NOBILCAM IMPAK Disc is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Huge Dental Material Corporation. It received FDA 510(k) clearance on 2025-08-01 under 510(k) number K251252. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOBILCAM IMPAK Disc?

NOBILCAM IMPAK Disc is a medical device that received FDA 510(k) clearance on 2025-08-01. The listed applicant is Shandong Huge Dental Material Corporation. The 510(k) number is K251252.

When did NOBILCAM IMPAK Disc receive FDA 510(k) clearance?

NOBILCAM IMPAK Disc received FDA 510(k) clearance on 2025-08-01, under 510(k) number K251252.

Who is the listed applicant for NOBILCAM IMPAK Disc?

The FDA 510(k) record lists Shandong Huge Dental Material Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOBILCAM IMPAK Disc?

The FDA product code for NOBILCAM IMPAK Disc is MQC.

Other records listing Shandong Huge Dental Material Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MQC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemviaK241729Hard Splint & Thermo-Adaptive SplintWhip Mix CorporationK243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, LLCK231775GR Resin System MSIPro3Dure Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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