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FDA 510(k)

MIST IC

K-Number: K243009 · 2025-06-24

ApplicantImagine Milling Technologies, LLC
Decision Date2025-06-24
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIST IC is the device name listed in this FDA 510(k) record. The listed applicant is Imagine Milling Technologies, LLC. It received FDA 510(k) clearance on 2025-06-24 under 510(k) number K243009. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIST IC?

MIST IC is a medical device that received FDA 510(k) clearance on 2025-06-24. The listed applicant is Imagine Milling Technologies, LLC. The 510(k) number is K243009.

When did MIST IC receive FDA 510(k) clearance?

MIST IC received FDA 510(k) clearance on 2025-06-24, under 510(k) number K243009.

Who is the listed applicant for MIST IC?

The FDA 510(k) record lists Imagine Milling Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIST IC?

The FDA product code for MIST IC is NHA.

Other records listing Imagine Milling Technologies, LLC 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.

K261122MIST ICK222368MIST ICK182246MIST IC

Related Devices (Code: NHA)

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.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

Official Source

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

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