BD Zygoma Implant
The BD Zygoma Implant supports fixed or removable dental prostheses in the upper jaw for partially edentulous or full-arch restorations. Its use is restricted to ZAGA Class 4 anatomy.…
The BD Zygoma Implant supports fixed or removable dental prostheses in the upper jaw for partially edentulous or full-arch restorations. Its use is restricted to ZAGA Class 4 anatomy. Immediate function requires good primary stability and appropriate occlusal loading.
The implant is made from commercially pure grade 4 titanium with an SLA surface treatment. It provides the implanted support to which the restorative components are connected. The BD design is one of the zygomatic implant configurations in the MegaGen system.
Size Range
The BD configuration is described with a 4.2 mm diameter and lengths from 30 to 57.5 mm.
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 | Megagen Implant Co., Ltd., South Korea |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K251232 |
| Record published | 2026-07-02 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BDZ4052 | In distribution | |
| BDZ4045 | In distribution | |
| BDZ4050 | In distribution | |
| BDZ4047 | In distribution | |
| BDZ4040 | In distribution | |
| BDZ4055 | In distribution | |
| BDZ4037 | In distribution | |
| BDZ4042 | In distribution | |
| BDZ4057 | In distribution | |
| BDZ4035 | In distribution | |
| BDZ4030 | In distribution | |
| BDZ4032 | 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 |
|---|---|
| K251232 | 2026-06-18 |
| K241972 | 2024-12-27 |
| K231967 | 2023-12-07 |
| K230618 | 2023-10-11 |
| K223339 | 2023-07-18 |
| K211812 | 2023-01-06 |
| K203554 | 2021-08-28 |
| K210161 | 2021-06-22 |
| K192347 | 2019-11-14 |
| K182448 | 2019-10-09 |
| K191127 | 2019-10-08 |
| K150537 | 2015-07-21 |
| K140091 | 2014-12-12 |
| K123988 | 2013-08-15 |
| K123870 | 2013-03-27 |
| K122231 | 2012-10-04 |
| K081302 | 2008-08-15 |
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.