Astra Tech Implant System®
Astra Tech Implant EV 3.0 S - 8 mm OsseoSpeed®
7manufacturers in China registered for this device type
305catalogue numbers in this listing
1510(k) clearance
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 | Dentsply Implants Manufacturing GmbH, Germany |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2015-10-24 |
| Record revised | 2025-10-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Storage in the original packaging, in a dry place, at normal room temperature. |
| Distribution end date | 2025-11-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 24974 | In distribution | |
| 24281 | In distribution | |
| 24123 | In distribution | |
| 24407 | In distribution | |
| 24421 | In distribution | |
| 24289 | In distribution | |
| 24234 | In distribution | |
| 22967 | In distribution | |
| 24237 | In distribution | |
| 24911 | In distribution | |
| 24577 | In distribution | |
| 26219 | In distribution | |
| 24945 | In distribution | |
| 26224 | In distribution | |
| 24058 | In distribution | |
| 26301 | In distribution | |
| 24399 | In distribution | |
| 24586 | In distribution | |
| 24584 | In distribution | |
| 24953 | In distribution | |
| 24439 | In distribution | |
| 24057 | In distribution | |
| 22185 | In distribution | |
| 24896 | In distribution | |
| 24131 | In distribution | |
| 22184 | In distribution | |
| 24290 | In distribution | |
| 24124 | In distribution | |
| 24050 | In distribution | |
| 24245 | In distribution | |
| 24528 | In distribution | |
| 24010 | In distribution | |
| 24905 | In distribution | |
| 24400 | In distribution | |
| 24898 | In distribution | |
| 24965 | In distribution | |
| 24246 | In distribution | |
| 24587 | In distribution | |
| 24113 | In distribution | |
| 24954 | In distribution | |
| 24575 | In distribution | |
| 24232 | In distribution | |
| 24055 | In distribution | |
| 24973 | In distribution | |
| 22720 | In distribution | |
| 24163 | In distribution | |
| 24932 | In distribution | |
| 22487 | In distribution | |
| 24068 | In distribution | |
| 24418 | In distribution | |
| 22844 | In distribution | |
| 24329 | In distribution | |
| 24280 | In distribution | |
| 24530 | In distribution | |
| 24537 | In distribution | |
| 24231 | In distribution | |
| 24244 | In distribution | |
| 24893 | In distribution | |
| 24380 | In distribution | |
| 24052 | In distribution | |
| 24583 | In distribution | |
| 24529 | In distribution | |
| 24383 | In distribution | |
| 24983 | In distribution | |
| 22828 | In distribution | |
| 24984 | In distribution | |
| 24576 | In distribution | |
| 24233 | In distribution | |
| 24122 | In distribution | |
| 24291 | In distribution | |
| 24229 | In distribution | |
| 24904 | In distribution | |
| 24375 | In distribution | |
| 26250 | In distribution | |
| 24048 | In distribution | |
| 24063 | In distribution | |
| 24941 | In distribution | |
| 24402 | In distribution | |
| 22799 | In distribution | |
| 24162 | In distribution | |
| 24449 | In distribution | |
| 24243 | In distribution | |
| 24160 | In distribution | |
| 24448 | In distribution | |
| 24420 | In distribution | |
| 24121 | In distribution | |
| 24222 | In distribution | |
| 24955 | In distribution | |
| 22061 | In distribution | |
| 24220 | In distribution | |
| 24982 | In distribution | |
| 22798 | In distribution | |
| 24903 | In distribution | |
| 24931 | In distribution | |
| 24934 | In distribution | |
| 24906 | In distribution | |
| 24285 | In distribution | |
| 24401 | In distribution | |
| 24247 | In distribution | |
| 24894 | In distribution | |
| 24288 | In distribution | |
| 24159 | In distribution | |
| 24916 | In distribution | |
| 22060 | In distribution | |
| 24092 | In distribution | |
| 24579 | In distribution | |
| 24901 | In distribution | |
| 24378 | In distribution | |
| 26225 | In distribution | |
| 24379 | In distribution | |
| 24930 | In distribution | |
| 24951 | In distribution | |
| 22843 | In distribution | |
| 24899 | In distribution | |
| 24328 | In distribution | |
| 24942 | In distribution | |
| 24001 | In distribution | |
| 24239 | In distribution | |
| 24907 | In distribution | |
| 24972 | In distribution | |
| 24940 | In distribution | |
| 24912 | In distribution | |
| 22167 | In distribution | |
| 24582 | In distribution | |
| 24112 | In distribution | |
| 26222 | In distribution | |
| 24051 | In distribution | |
| 24047 | In distribution | |
| 24933 | In distribution | |
| 24153 | In distribution | |
| 24287 | In distribution | |
| 24403 | In distribution | |
| 24900 | In distribution | |
| 24527 | In distribution | |
| 24286 | In distribution | |
| 26226 | In distribution | |
| 24238 | In distribution | |
| 24581 | In distribution | |
| 24971 | In distribution | |
| 24574 | In distribution | |
| 22486 | In distribution | |
| 24377 | In distribution | |
| 24578 | In distribution | |
| 24914 | In distribution | |
| 24606 | In distribution | |
| 24585 | In distribution | |
| 24224 | In distribution | |
| 24935 | In distribution | |
| 24422 | In distribution | |
| 24154 | In distribution | |
| 24897 | In distribution | |
| 24235 | In distribution | |
| 24049 | In distribution | |
| 26252 | In distribution | |
| 24908 | In distribution | |
| 26221 | In distribution | |
| 22722 | In distribution | |
| 24221 | In distribution | |
| 22966 | In distribution | |
| 24952 | In distribution | |
| 24161 | In distribution | |
| 24002 | In distribution | |
| 25044 | In distribution | |
| 24236 | In distribution | |
| 24248 | In distribution | |
| 24158 | In distribution | |
| 24382 | In distribution | |
| 24700 | In distribution | |
| 24943 | In distribution | |
| 24088 | In distribution | |
| 24381 | In distribution | |
| 24915 | In distribution | |
| 22852 | In distribution | |
| 26220 | In distribution | |
| 22968 | In distribution | |
| 24411 | In distribution | |
| 24909 | In distribution | |
| 24172 | In distribution | |
| 22447 | In distribution | |
| 24228 | In distribution | |
| 24910 | In distribution | |
| 24895 | In distribution | |
| 24347 | In distribution | |
| 24975 | In distribution | |
| 24409 | In distribution | |
| 24913 | In distribution | |
| 24000 | In distribution | |
| 24447 | In distribution | |
| 24056 | In distribution | |
| 24230 | In distribution | |
| 24198 | In distribution | |
| 22721 | In distribution | |
| 24944 | In distribution | |
| 24539 | In distribution | |
| 24902 | In distribution | |
| 24538 | In distribution | |
| 24580 | In distribution | |
| 24962 | In distribution | |
| 24939 | In distribution | |
| 24054 | In distribution | |
| 24410 | In distribution | |
| 24223 | In distribution | |
| 24292 | In distribution | |
| 24053 | In distribution | |
| 24892 | In distribution | |
| 24374 | In distribution | |
| 24408 | In distribution | |
| 26223 | In distribution | |
| 24964 | In distribution | |
| 25647 | In distribution | |
| 22827 | In distribution | |
| 24961 | In distribution | |
| 24963 | In distribution | |
| 24376 | In distribution | |
| 24419 | In distribution | |
| 24348 | In distribution | |
| 24423 | In distribution | |
| 24607 | In distribution | |
| 24398 | In distribution | |
| 24406 | In distribution | |
| 24208 | In distribution | |
| 22790 | Withdrawn | |
| 24080 | Withdrawn | |
| 24091 | Withdrawn | |
| 24005 | Withdrawn | |
| 24562 | Withdrawn | |
| 24013 | Withdrawn | |
| 24062 | Withdrawn | |
| 25041 | Withdrawn | |
| 24004 | Withdrawn | |
| 25038 | Withdrawn | |
| 24923 | Withdrawn | |
| 24125 | Withdrawn | |
| 24110 | Withdrawn | |
| 24064 | Withdrawn | |
| 24180 | Withdrawn | |
| 25031 | Withdrawn | |
| 24560 | Withdrawn | |
| 24283 | Withdrawn | |
| 25029 | Withdrawn | |
| 24284 | Withdrawn | |
| 24127 | Withdrawn | |
| 24089 | Withdrawn | |
| 25648 | Withdrawn | |
| 25036 | Withdrawn | |
| 24126 | Withdrawn | |
| 24171 | Withdrawn | |
| 24921 | Withdrawn | |
| 24129 | Withdrawn | |
| 24917 | Withdrawn |
Showing 250 of 300 catalogue numbers.
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 |
|---|---|
| K130999 | 2013-10-25 |
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.