Mist Ic

FDA 510(k) K261122 · Imagine Milling Technologies, LLC

Substantially Equivalent

510(k) numberK261122

Submission

Device name
Mist Ic
Applicant
Imagine Milling Technologies, LLC
Chantilly, VA, US
Received
April 3, 2026
Decision date
June 27, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NHA – Abutment, Implant, Dental, Endosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3630
Specialty
Dental
Implant
Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Other 510(k)s with product code NHA

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K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…NHA · Traditional Nobel Biocare AB08/06/2026SE
K261147Neodent Implant System - NeoConvert FitNHA · Traditional JJGC Indústria e Comércio de Materiais Dentários…07/01/2026SE
K260061BioHorizons CEREC Compatible Ti-BasesNHA · Traditional BioHorizons Implant Systems, Inc.06/26/2026SE
K253922Neodent Scannable Healing AbutmentNHA · Traditional JJGC Indústria e Comércio de Materiais Dentários…06/15/2026SE
K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)NHA · Abbreviated Smart Denture Conversions, LLC06/11/2026SE
K260564DESS Dental Smart SolutionsNHA · Traditional Terrats Medical SL06/09/2026SE
K252904SIC Abutments including CAD/CAM SolutionsNHA · Traditional Sic Invent AG06/03/2026SE
K253774Elos Accurate® Denture Fixation SystemNHA · Traditional Elos Medtech Pinol A/S05/20/2026SE
K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHA · Traditional Hiossen, Inc.05/14/2026SE
K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueNHA · Traditional Institut Straumann AG05/07/2026SE

More from Institut Straumann AG

510(k)DeviceDecision
K243009Mist IcNHA · Traditional 06/24/2025SE
K222368Mist IcNHA · Traditional 12/01/2022SE
K182246Mist IcNHA · Traditional 04/16/2019SE

Questions and answers

When was Mist Ic cleared by the FDA?

Mist Ic (K261122) received a 510(k) decision of Substantially Equivalent on June 27, 2026, 85 days after the submission was received.

What is the product code of K261122?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.