Friadent®
Transfer Coping Transfer Technique with TransferCap D4.5/GH3
7manufacturers in China registered for this device type
525catalogue 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 | 2020-12-07 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| 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, at room temperature in a dry place away from sunlight. |
| Distribution end date | 2025-10-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32454240 | In distribution | |
| 32454251 | In distribution | |
| 32453132 | In distribution | |
| 32454410 | In distribution | |
| 32451160 | In distribution | |
| 32461255 | In distribution | |
| 32454210 | In distribution | |
| 32453142 | In distribution | |
| 32453133 | In distribution | |
| 32461260 | In distribution | |
| 32454303 | In distribution | |
| 32451253 | In distribution | |
| 32462152 | In distribution | |
| 32454230 | In distribution | |
| 32451345 | In distribution | |
| 32451363 | In distribution | |
| 32469647 | In distribution | |
| 32462845 | In distribution | |
| 32454850 | In distribution | |
| 32451630 | In distribution | |
| 32451463 | In distribution | |
| 32453242 | In distribution | |
| 32461440 | In distribution | |
| 32451343 | In distribution | |
| 32462162 | In distribution | |
| 32469960 | In distribution | |
| 32452620 | In distribution | |
| 32453262 | In distribution | |
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| 32464407 | In distribution | |
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| 32451245 | In distribution | |
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| 32451242 | In distribution | |
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| 32469560 | In distribution | |
| 32452650 | In distribution | |
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| 32462252 | In distribution | |
| 32469540 | In distribution | |
| 32453263 | In distribution | |
| 32453253 | In distribution | |
| 32453265 | In distribution | |
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| 32462163 | In distribution | |
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| 32462143 | In distribution | |
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| 32462141 | In distribution | |
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| 32462732 | Withdrawn | |
| 32454410 | Withdrawn | |
| 32464200 | Withdrawn | |
| 32453200 | Withdrawn | |
| 32454660 | Withdrawn | |
| 32462841 | Withdrawn | |
| 32452460 | Withdrawn | |
| 32454650 | Withdrawn | |
| 32469647 | Withdrawn | |
| 32453201 | Withdrawn | |
| 32469648 | Withdrawn | |
| 32451631 | Withdrawn | |
| 32462221 | Withdrawn | |
| 32454251 | Withdrawn | |
| 32464401 | 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 |
| 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 |
| Ankylos® | Dentsply Implants Manufacturing GmbH | 391 |
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.