Aeton Medical
4.8mm Impression Coping Assembly - Natural
7manufacturers in China registered for this device type
66catalogue numbers in this listing
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 | Aetonmedical LLC |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Record published | 2020-11-06 |
| Record revised | 2021-02-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STHC483 | In distribution | |
| BNCH483 | In distribution | |
| STAN654 | In distribution | |
| BRBH604 | In distribution | |
| STRBC65 | In distribution | |
| STTPC65 | In distribution | |
| STHC481 | In distribution | |
| AMSTAS485 | In distribution | |
| BRBH504 | In distribution | |
| BNCH363 | In distribution | |
| STTPC48 | In distribution | |
| BNBH505 | In distribution | |
| STAN487 | In distribution | |
| AMSTAS484 | In distribution | |
| BRBH656 | In distribution | |
| STHC484 | In distribution | |
| STFTC48 | In distribution | |
| STICA484 | In distribution | |
| STFBC48 | In distribution | |
| BRCH606 | In distribution | |
| STHC657 | In distribution | |
| STAB654 | In distribution | |
| BNBH404 | In distribution | |
| AMSTAS655 | In distribution | |
| BNBH504 | In distribution | |
| BRBH605 | In distribution | |
| BRBH704 | In distribution | |
| STICA487 | In distribution | |
| STHC482 | In distribution | |
| STAN655 | In distribution | |
| BNBH506 | In distribution | |
| STFBC65 | In distribution | |
| BNCH482 | In distribution | |
| BRCH604 | In distribution | |
| BNCH362 | In distribution | |
| STICA654 | In distribution | |
| STRBC48 | In distribution | |
| BFRH | In distribution | |
| BNBH604 | In distribution | |
| STFTC65 | In distribution | |
| BRCH602 | In distribution | |
| STHC487 | In distribution | |
| AMSTAS654 | In distribution | |
| BNCH484 | In distribution | |
| BRBH654 | In distribution | |
| STAB487 | In distribution | |
| BRBH505 | In distribution | |
| AMSTAS487 | In distribution | |
| STICA485 | In distribution | |
| STAN484 | In distribution | |
| STAB484 | In distribution | |
| BFNH | In distribution | |
| BRCH603 | In distribution | |
| STAN485 | In distribution | |
| STICA655 | In distribution | |
| STHC653 | In distribution | |
| BNBH405 | In distribution | |
| STAB655 | In distribution | |
| BNCH485 | In distribution | |
| BNCH365 | In distribution | |
| STAB485 | In distribution | |
| STHC654 | In distribution | |
| STIC65 | In distribution | |
| STHC652 | In distribution | |
| BRCH452 | In distribution | |
| STIC48 | 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
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.