Manufacturer registered with FDA
Imagine Milling Technologies, LLC
Chantilly, VA, United States. Lists 12 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 12
- Brands and models
- 23
- 510(k) clearances
- 42019–2026
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Imagine Milling Technologies, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | ALLONUS Tech ProstheticsCustomized AbutmentDESS Dental Smart SolutionsGeo AbutmentMIST ICPre-Milled BlankSIC invent Dental Implant Systems | 2019 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Arena Star, MontblancDD Bio ZX²DD cubeX² MLNon-Sterile Zirconia Block (Model: Arena Monoblanc, Trione C, Trione HT+) | 2020 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | SIC invent Dental Implant SystemsSICtapered & SICvantage tapered | 2024 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Harvest Dental Polymer BlocksNextDent Denture/E-Denture | 2018 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Lister | Dental LT Clear; E-Guard; NextDent Ortho Clear; NextDent Ortho Clear E-Guard; NextDent Ortho Rigid | 2018 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Harvest Dental Polymer Blocks | 2023 |
| Shellac Base PlateEEA · Class 1 | — | Lister | NextDent Try-In | 2018 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | Penguin RFA MulTipegs | 2024 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Lister | E-Dent 400; NextDent C&B; NextDent C&B MFH | 2018 |
| Backing and Facing Artificial TeethELK · Class 1 | — | Lister | NextDent C&B; NextDent C&B MFH | 2018 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | Dental SG; E-Guide Tint; NextDent SG | 2018 |
| Dental Implant Surgical TrayOFY · Class 1 | Implant instruments & surgical kits | Maker | SIC Drill | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Imagine Milling Technologies, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Jun 2026 | K261122 | MIST IC | NHA Endosseous Dental Implant Abutment |
| 24 Jun 2025 | K243009 | MIST IC | NHA Endosseous Dental Implant Abutment |
| 1 Dec 2022 | K222368 | MIST IC | NHA Endosseous Dental Implant Abutment |
| 16 Apr 2019 | K182246 | MIST IC | NHA Endosseous Dental Implant Abutment |
Some of these clearances are listed with FDA today by another company: Army Dental Laboratory (2), GeoMedi Co., Ltd. (1).
Also lists devices cleared under other names
Imagine Milling Technologies, LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: ARUM DENTISTRY Co., Ltd (2), SIC invent AG (2), ALLONUS Tech Co., Ltd. (1), Fine Advanced Compound Co., Ltd. (1), Harvest Dental Products, LLC (1), Vertex-Dental B.V. (1), Tellos Medical AB (1), Dental Direkt GmbH (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Dec 2024 | K241616 | ALLONUS Tech Prosthetics | ALLONUS Tech Co., Ltd. | NHA Endosseous Dental Implant Abutment |
| 28 Apr 2023 | K223634 | Customized Abutment | ARUM DENTISTRY Co., Ltd | NHA Endosseous Dental Implant Abutment |
| 27 Feb 2023 | K223253 | Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) | ARUM DENTISTRY Co., Ltd | EIH Porcelain Powder |
| 17 Mar 2022 | K210489 | SICtapered & SICvantage tapered | SIC invent AG | DZE Root-Form Endosseous Implant |
| 20 Dec 2019 | K190112 | Non-Sterile Zirconia Block | Fine Advanced Compound Co., Ltd. | EIH Porcelain Powder |
| 12 Dec 2018 | K180578 | Harvest Dental Polymer Blocks | Harvest Dental Products, LLC | EBG Resin Temporary Crown and Bridge |
| 5 Apr 2018 | K173207 | SIC invent Dental Implant Systems | SIC invent AG | DZE Root-Form Endosseous Implant |
| 30 Jun 2017 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | EBI Rebasing Repairing Relining Denture Resin |
| 7 Jan 2016 | K143445 | Tellos ISQ Buddy | Tellos Medical AB | EKX Ac-Powered Direct Drive Handpiece |
| 26 Mar 2015 | K150196 | DD cubeX2 | Dental Direkt GmbH | EIH Porcelain Powder |
| 11 Feb 2015 | K142987 | DD Bio Z, DD Bio ZX(square), DD BioZX(square) color | Dental Direkt of Amerika UG (Haftungsbeschraenkt) | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| IMAGINE MILLING TECHNOLOGIES, LLCFDA reg. 3009727738 | Chantilly, VA, United States | Contract manufacturer, Manufacturer for export, Manufacturer, Remanufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10044468). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.