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Data / Medical devices / United States / Imagine Milling Technologies, LLC

Imagine Milling Technologies, LLC: FDA-registered device maker in Chantilly, VA, United States, 15 510(k) clearances

Imagine Milling Technologies, LLC is registered with the FDA (registration 3009727738) in Chantilly, VA, United States. It lists 13 device types. The FDA files 15 510(k) clearances under its listings, the newest dated June 27, 2026. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Imagine Milling Technologies, LLC
FDA registration number
3009727738
Address
14220 Sullyfield Cir Ste B, Chantilly, VA, United States, 20151
Owner or operator
Imagine Milling Technologies, LLC (10044468)
Roles
Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer, Repackager or relabeler, Specification developer
First device listed
December 6, 2018
Registered through
2026
Brand names listed
ALLONUS Tech Prosthetics, Arena Star, Montblanc, Customized Abutment, DD Bio ZX², DD cubeX² ML, DESS Dental Smart Solutions, Dental LT Clear; E-Guard; NextDent Ortho Clear; NextDent Ortho Clear E-Guard; NextDent Ortho Rigid, Dental SG; E-Guide Tint; NextDent SG and more

Devices it lists

DeviceProduct codeClassRoleSource
Abutment, Implant, Dental, EndosseousNHA2Contract manufacturer, Manufacturer, Remanufacturer, Specification developeraccessdata.fda.gov
Accessories, Implant, Dental, EndosseousNDP1Repackager or relabeleraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Dental Implant Surgical TrayOFY1Manufacturer for exportaccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Repackager or relabeleraccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Specification developeraccessdata.fda.gov
Maintainer, Space Preformed, OrthodonticDYT1Repackager or relabeleraccessdata.fda.gov
Mouthguard, PrescriptionMQCURemanufacturer, Repackager or relabeleraccessdata.fda.gov
Plate, Base, ShellacEEA1Repackager or relabeleraccessdata.fda.gov
Powder, PorcelainEIH2Contract manufacturer, Remanufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Resin, Denture, Relining, Repairing, RebasingEBI2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Teeth, Artificial, Backing And FacingELK1Repackager or relabeleraccessdata.fda.gov
Teeth, Artificial, Posterior With Metal InsertELJ1Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 27, 2026K261122MIST ICNHASubstantially EquivalentImagine Milling Technologies, LLCaccessdata.fda.gov
June 24, 2025K243009MIST ICNHASubstantially EquivalentImagine Milling Technologies, LLCaccessdata.fda.gov
December 17, 2024K241616ALLONUS Tech ProstheticsNHASubstantially EquivalentAllonus Tech Co., Ltd.accessdata.fda.gov
April 28, 2023K223634Customized AbutmentNHASubstantially EquivalentArum Dentistry Co., Ltd.accessdata.fda.gov
February 27, 2023K223253Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)EIHSubstantially EquivalentArum Dentistry Co., Ltd.accessdata.fda.gov
December 1, 2022K222368MIST ICNHASubstantially EquivalentImagine Milling Technologies, LLCaccessdata.fda.gov
March 17, 2022K210489SICtapered & SICvantage taperedDZESubstantially EquivalentSic Invent AGaccessdata.fda.gov
December 20, 2019K190112Non-Sterile Zirconia BlockEIHSubstantially EquivalentFine Advanced Compound Co., Ltd.accessdata.fda.gov
April 16, 2019K182246MIST ICNHASubstantially EquivalentImagine Milling Technologies, LLCaccessdata.fda.gov
December 12, 2018K180578Harvest Dental Polymer BlocksEBGSubstantially EquivalentHarvest Dental Products, LLCaccessdata.fda.gov
April 5, 2018K173207SIC invent Dental Implant SystemsDZESubstantially EquivalentSic Invent AGaccessdata.fda.gov
June 30, 2017K162572NextDent Denture, E-DentureEBISubstantially EquivalentVertex-Dental B.V.accessdata.fda.gov
January 7, 2016K143445Tellos ISQ BuddyEKXSubstantially EquivalentTellos Medical ABaccessdata.fda.gov
March 26, 2015K150196DD cubeX2EIHSubstantially EquivalentDental Direkt GmbHaccessdata.fda.gov
February 11, 2015K142987DD Bio Z, DD Bio ZX(square), DD BioZX(square) colorEIHSubstantially EquivalentDental Direkt of Amerika UG (Haftungsbeschraenkt)accessdata.fda.gov

Compare with other makers

Updated June 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.