Vortex
“The AIM Reference Marker is a temporary accessory used during digital implant workflows to provide spatial reference for scanning and photogrammetry procedures. The device is not intended…
“The AIM Reference Marker is a temporary accessory used during digital implant workflows to provide spatial reference for scanning and photogrammetry procedures. The device is not intended for fixation, stabilization, or load-bearing applications.”
Who Else Makes It
Concentrated in Jiangsu (3), Sichuan (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Basic (Chengdu) Medical Device Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 1 |
| Dongguan Xinlonghong Hardware Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| BIO Concept Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Louisiana Dental Implant LAB, United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K961384 |
| Record published | 2025-09-02 |
| Record revised | 2025-01-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2026-01-07 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17° 3.5*2.0mmH | In distribution | |
| StrMUAZ-5.7*1.0 | In distribution | |
| 17° 4.5*2.0mmH | In distribution | |
| 30° 4.5*3.0mmH | In distribution | |
| StrMUAB-3.5*1.0 | In distribution | |
| BNREFMUA1413V2 | In distribution | |
| 1.72mm | In distribution | |
| StrMUAZ-4.5*1.0 | In distribution | |
| 1.6mm Screw | In distribution | |
| TiPreMillZ-5.7 | In distribution | |
| BNREFMUA149V2 | In distribution | |
| TiPreMillB-3.5 | In distribution | |
| StrMUAB-4.5*1.0 | In distribution | |
| Ti Base | In distribution | |
| TiPreMillZ-4.5 | In distribution | |
| 1.4 mm screw | In distribution | |
| TiPreMillB-5.7 | In distribution | |
| TiPreMillB-4.5 | In distribution | |
| BNREFMUA1413 | In distribution | |
| 30° 3.5*3.0mmH | In distribution | |
| BNREFMUA149 | In distribution | |
| TiPreMillZ-3.5 | In distribution | |
| StrMUAB-5.7*1.0 | In distribution | |
| BNREFMUA146V2 | In distribution | |
| StrMUAZ-3.5*1.0 | In distribution | |
| VRXBRESCR1.4 | Withdrawn | |
| 1.4mm Screw | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 920 |
| Osstem Implant System | Osstem Implant Co., Ltd. | 788 |
| Magicore | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 744 |
| Implant, Endosseous, Root-Form | Southern Implants (PTY) Ltd | 608 |
| ITL Dental | Emery Enterprises Inc. | 603 |
| Magicore S | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 560 |
| Friadent® | Dentsply Implants Manufacturing GmbH | 525 |
| Sphero Block Normo | Rhein 83 SRL | 489 |
| Neobiotech Implant System | Neobiotech Co., Ltd. | 483 |
| KJ Mini Implant System | Kjmeditech.co., Ltd. | 448 |
| Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | 418 |
| Leone SPA | Leone SPA | 404 |
Showing 12 of 2,762. All products under Implant, Endosseous, Root-Form
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P800035 | 2001-10-04 | PERI-OSS | Curasan AG |
| P860012 | 1988-10-28 | ALVEOFORM TM BIOGRAFT | Collagen Corp. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.