Astra Tech Implant System® EV
Astra Tech Implant EV Profile 4.8 PC - 17 mm OsseoSpeed®
7manufacturers in China registered for this device type
326catalogue 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 | 2025-10-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25306 | In distribution | |
| 25921 | In distribution | |
| 25233 | In distribution | |
| 26416 | In distribution | |
| 26320 | In distribution | |
| 25917 | In distribution | |
| 25254 | In distribution | |
| 26360 | In distribution | |
| 25582 | In distribution | |
| 25329 | In distribution | |
| 25287 | In distribution | |
| 25504 | In distribution | |
| 25558 | In distribution | |
| 26302 | In distribution | |
| 25912 | In distribution | |
| 25232 | In distribution | |
| 26342 | In distribution | |
| 25581 | In distribution | |
| 25305 | In distribution | |
| 26304 | In distribution | |
| 25559 | In distribution | |
| 25692 | In distribution | |
| 25906 | In distribution | |
| 25204 | In distribution | |
| 25206 | In distribution | |
| 25205 | In distribution | |
| 25303 | In distribution | |
| 25902 | In distribution | |
| 25336 | In distribution | |
| 25908 | In distribution | |
| 26313 | In distribution | |
| 25563 | In distribution | |
| 25215 | In distribution | |
| 25697 | In distribution | |
| 26406 | In distribution | |
| 25501 | In distribution | |
| 25565 | In distribution | |
| 25313 | In distribution | |
| 25263 | In distribution | |
| 25267 | In distribution | |
| 26343 | In distribution | |
| 25345 | In distribution | |
| 25901 | In distribution | |
| 25203 | In distribution | |
| 25295 | In distribution | |
| 26334 | In distribution | |
| 25281 | In distribution | |
| 25331 | In distribution | |
| 25275 | In distribution | |
| 26411 | In distribution | |
| 25252 | In distribution | |
| 25686 | In distribution | |
| 25502 | In distribution | |
| 26316 | In distribution | |
| 26345 | In distribution | |
| 25616 | In distribution | |
| 26353 | In distribution | |
| 25698 | In distribution | |
| 26351 | In distribution | |
| 25953 | In distribution | |
| 26364 | In distribution | |
| 25332 | In distribution | |
| 25481 | In distribution | |
| 25309 | In distribution | |
| 26401 | In distribution | |
| 25370 | In distribution | |
| 25904 | In distribution | |
| 26346 | In distribution | |
| 25695 | In distribution | |
| 25227 | In distribution | |
| 26381 | In distribution | |
| 26412 | In distribution | |
| 25301 | In distribution | |
| 25576 | In distribution | |
| 26336 | In distribution | |
| 26314 | In distribution | |
| 25508 | In distribution | |
| 26355 | In distribution | |
| 25292 | In distribution | |
| 26415 | In distribution | |
| 25796 | In distribution | |
| 25496 | In distribution | |
| 25700 | In distribution | |
| 25617 | In distribution | |
| 26303 | In distribution | |
| 25335 | In distribution | |
| 25494 | In distribution | |
| 25374 | In distribution | |
| 25375 | In distribution | |
| 25798 | In distribution | |
| 25226 | In distribution | |
| 26402 | In distribution | |
| 25369 | In distribution | |
| 25256 | In distribution | |
| 26305 | In distribution | |
| 25506 | In distribution | |
| 25300 | In distribution | |
| 25510 | In distribution | |
| 26413 | In distribution | |
| 25223 | In distribution | |
| 25311 | In distribution | |
| 26365 | In distribution | |
| 26326 | In distribution | |
| 25361 | In distribution | |
| 25282 | In distribution | |
| 25507 | In distribution | |
| 26310 | In distribution | |
| 25340 | In distribution | |
| 25245 | In distribution | |
| 25367 | In distribution | |
| 25910 | In distribution | |
| 25373 | In distribution | |
| 25495 | In distribution | |
| 25276 | In distribution | |
| 26340 | In distribution | |
| 25913 | In distribution | |
| 26373 | In distribution | |
| 25568 | In distribution | |
| 25555 | In distribution | |
| 25905 | In distribution | |
| 25920 | In distribution | |
| 25561 | In distribution | |
| 25236 | In distribution | |
| 25247 | In distribution | |
| 25583 | In distribution | |
| 25689 | In distribution | |
| 26361 | In distribution | |
| 25907 | In distribution | |
| 25231 | In distribution | |
| 25690 | In distribution | |
| 26414 | In distribution | |
| 25365 | In distribution | |
| 26332 | In distribution | |
| 26344 | In distribution | |
| 25952 | In distribution | |
| 25572 | In distribution | |
| 26375 | In distribution | |
| 25799 | In distribution | |
| 25302 | In distribution | |
| 25274 | In distribution | |
| 25362 | In distribution | |
| 26384 | In distribution | |
| 25922 | In distribution | |
| 25916 | In distribution | |
| 26354 | In distribution | |
| 26331 | In distribution | |
| 25235 | In distribution | |
| 25701 | In distribution | |
| 25512 | In distribution | |
| 26362 | In distribution | |
| 26323 | In distribution | |
| 25366 | In distribution | |
| 26374 | In distribution | |
| 26333 | In distribution | |
| 25241 | In distribution | |
| 25344 | In distribution | |
| 26372 | In distribution | |
| 25637 | In distribution | |
| 25364 | In distribution | |
| 25294 | In distribution | |
| 26324 | In distribution | |
| 25338 | In distribution | |
| 25296 | In distribution | |
| 25557 | In distribution | |
| 26371 | In distribution | |
| 25693 | In distribution | |
| 25795 | In distribution | |
| 25334 | In distribution | |
| 25699 | In distribution | |
| 26403 | In distribution | |
| 26356 | In distribution | |
| 26341 | In distribution | |
| 25333 | In distribution | |
| 25342 | In distribution | |
| 25339 | In distribution | |
| 25575 | In distribution | |
| 25343 | In distribution | |
| 25567 | In distribution | |
| 25577 | In distribution | |
| 25307 | In distribution | |
| 25312 | In distribution | |
| 25337 | In distribution | |
| 25244 | In distribution | |
| 25214 | In distribution | |
| 25341 | In distribution | |
| 25298 | In distribution | |
| 25207 | In distribution | |
| 25265 | In distribution | |
| 26322 | In distribution | |
| 25688 | In distribution | |
| 25911 | In distribution | |
| 26311 | In distribution | |
| 25277 | In distribution | |
| 25578 | In distribution | |
| 26363 | In distribution | |
| 25304 | In distribution | |
| 25503 | In distribution | |
| 25264 | In distribution | |
| 25499 | In distribution | |
| 25293 | In distribution | |
| 25687 | In distribution | |
| 25283 | In distribution | |
| 25327 | In distribution | |
| 25511 | In distribution | |
| 25266 | In distribution | |
| 25289 | In distribution | |
| 25299 | In distribution | |
| 25498 | In distribution | |
| 26315 | In distribution | |
| 25580 | In distribution | |
| 25579 | In distribution | |
| 25918 | In distribution | |
| 25691 | In distribution | |
| 25914 | In distribution | |
| 25330 | In distribution | |
| 25288 | In distribution | |
| 25262 | In distribution | |
| 25363 | In distribution | |
| 25696 | In distribution | |
| 25571 | In distribution | |
| 26312 | In distribution | |
| 25284 | In distribution | |
| 25255 | In distribution | |
| 25919 | In distribution | |
| 25564 | In distribution | |
| 26301 | In distribution | |
| 25915 | In distribution | |
| 25923 | In distribution | |
| 25566 | In distribution | |
| 25246 | In distribution | |
| 25368 | In distribution | |
| 25569 | In distribution | |
| 26382 | In distribution | |
| 25290 | In distribution | |
| 25234 | In distribution | |
| 25253 | In distribution | |
| 25372 | In distribution | |
| 25224 | In distribution | |
| 25225 | In distribution | |
| 25497 | In distribution | |
| 26383 | In distribution | |
| 25371 | In distribution | |
| 25684 | In distribution | |
| 26352 | In distribution | |
| 25251 | In distribution | |
| 25328 | In distribution | |
| 25310 | In distribution | |
| 25273 | In distribution | |
| 25909 | In distribution | |
| 26325 | In distribution |
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.