Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Hard Splint & Thermo-Adaptive Splint

K-Number: K241729 · 2025-03-18

ApplicantWhip Mix Corporation
Decision Date2025-03-18
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

Hard Splint & Thermo-Adaptive Splint is the device name listed in this FDA 510(k) record. The listed applicant is Whip Mix Corporation. It received FDA 510(k) clearance on 2025-03-18 under 510(k) number K241729. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hard Splint & Thermo-Adaptive Splint?

Hard Splint & Thermo-Adaptive Splint is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is Whip Mix Corporation. The 510(k) number is K241729.

When did Hard Splint & Thermo-Adaptive Splint receive FDA 510(k) clearance?

Hard Splint & Thermo-Adaptive Splint received FDA 510(k) clearance on 2025-03-18, under 510(k) number K241729.

Who is the listed applicant for Hard Splint & Thermo-Adaptive Splint?

The FDA 510(k) record lists Whip Mix Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hard Splint & Thermo-Adaptive Splint?

The FDA product code for Hard Splint & Thermo-Adaptive Splint is MQC.

Other records listing Whip Mix 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.

K190107VeriSplintK152443Vericore Gradient Temporary Disc

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 NightGuardRemviaK251252NOBILCAM IMPAK DiscShandong Huge Dental Material 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.

↑