Magden Dental Implant System
MagDen is a dental implant system with a bone-anchoring fixture, restorative abutments, a healing abutment and a cover screw. The fixtures are intended specifically for replacing upper…
MagDen is a dental implant system with a bone-anchoring fixture, restorative abutments, a healing abutment and a cover screw. The fixtures are intended specifically for replacing upper lateral incisors and lower central or lateral incisors.
The fixture is Ti-6Al-4V ELI titanium alloy with a sandblasted, large-grit, acid-etched surface. Mini and standard restorative abutments are SUS444 stainless steel with a titanium-nitride coating and are intended only for multiple-unit restorations.
Listed Item
The MagDen Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function.
Component Materials and Sizes
Healing abutments and cover screws use Ti-6Al-4V ELI titanium alloy without surface treatment. Fixture diameters include 2.2, 2.7 and 3.2 mm, with different lengths for each diameter. Fixtures are supplied gamma sterilized. Material and surface treatment therefore depend on the selected component.
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 | Shinhung MST Co., Ltd., South Korea |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Manufacturer |
| 510(k) | K162867 |
| Record published | 2026-04-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 1 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MI2711RSS | In distribution | |
| MI3207NLS | In distribution | |
| MI2708RLS | In distribution | |
| MI2207NLS | In distribution | |
| MI2707NSS | In distribution | |
| MI3210NSS | In distribution | |
| MI3208RSS | In distribution | |
| MI3207RLS | In distribution | |
| MI3211RSS | In distribution | |
| MI2708NLS | In distribution | |
| MI2213NLS | In distribution | |
| MI2708RSS | In distribution | |
| MI2713NLS | In distribution | |
| MI2713NSS | In distribution | |
| MI2707NLS | In distribution | |
| MI2710RSS | In distribution | |
| MI3211NLS | In distribution | |
| MI2710RLS | In distribution | |
| MI2710NSS | In distribution | |
| MI3211RLS | In distribution | |
| MI2711RLS | In distribution | |
| MI3210RLS | In distribution | |
| MI3208NLS | In distribution | |
| MI3210RSS | In distribution | |
| MI3213RSS | In distribution | |
| MI2707RLS | In distribution | |
| MI3211NSS | In distribution | |
| MI2210NLS | In distribution | |
| MI2713RLS | In distribution | |
| MI3208NSS | In distribution | |
| MI3213NLS | In distribution | |
| MI3207NSS | In distribution | |
| MI2208NLS | In distribution | |
| MI2708NSS | In distribution | |
| MI2211NLS | In distribution | |
| MI3207RSS | In distribution | |
| MI3213RLS | In distribution | |
| MI2707RSS | In distribution | |
| MI2713RSS | In distribution | |
| MI3210NLS | In distribution | |
| MI2711NSS | In distribution | |
| MI3208RLS | In distribution | |
| MI2711NLS | In distribution | |
| MI3213NSS | In distribution | |
| MI2710NLS | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221752 | 2023-06-04 |
| K221317 | 2023-01-13 |
| K162867 | 2017-07-26 |
| K160106 | 2016-08-26 |
| K123155 | 2013-10-31 |
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.