Xpeed AnyRidge Internal Fixture
Xpeed AnyRidge Internal Fixture is a two-stage, root-form dental implant body used with compatible abutments to support dental restorations. The fixture is commercially pure Grade 4…
Xpeed AnyRidge Internal Fixture is a two-stage, root-form dental implant body used with compatible abutments to support dental restorations. The fixture is commercially pure Grade 4 titanium with a sandblasted and acid-etched surface.
The system includes normal-ridge and low-ridge fixture types in different diameters and lengths. Restorative components provide screw-retained or cement-retained crown, bridge or overdenture configurations.
Listed Item
XPEED AnyRidge Internal Implant System (C4.0) Ø6.0/ L10.0
Ridge and Loading Configurations
Larger fixtures are intended for the molar region with delayed loading. The stated immediate-loading option applies to implants below 6.0 mm diameter only when primary stability and occlusal loading are appropriate. Fixture and restoration selection follows the specific anatomical and loading configuration.
7manufacturers in China registered for this device type
191catalogue numbers in this listing
17510(k) clearances naming this product code
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) | K140091 |
| Record published | 2015-06-23 |
| Record revised | 2026-06-22 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FANIHX5511 | In distribution | |
| AR435011 | In distribution | |
| AR406010 | In distribution | |
| FANIHX5015 | In distribution | |
| AR384515 | In distribution | |
| AR384505 | In distribution | |
| FANIHX5007S | In distribution | |
| FALIHX6507 | In distribution | |
| AR385515 | In distribution | |
| AR385515 | In distribution | |
| AR385005 | In distribution | |
| FALIHX6008 | In distribution | |
| AR435511 | In distribution | |
| FALIHX8013 | In distribution | |
| FALIHX8015 | In distribution | |
| AR435015 | In distribution | |
| FALIHX7011 | In distribution | |
| FANIHX3515 | In distribution | |
| FANIHX5507S | In distribution | |
| AR435015 | In distribution | |
| AR436010 | In distribution | |
| AR334005 | In distribution | |
| AR435507 | In distribution | |
| AR485511 | In distribution | |
| AR385510 | In distribution | |
| AR436007 | In distribution | |
| FANIHX5510S | In distribution | |
| FANIHX3508 | In distribution | |
| AR335005 | In distribution | |
| AR436007 | In distribution | |
| FANIHX5013 | In distribution | |
| AR385013 | In distribution | |
| FALIHX6510 | In distribution | |
| AR436008 | In distribution | |
| FANIHX5518 | In distribution | |
| AR385518 | In distribution | |
| FALIHX7508 | In distribution | |
| FANIHX5011 | In distribution | |
| FANIHX4513 | In distribution | |
| FANIHX5008 | In distribution | |
| AR435515 | In distribution | |
| AR385513 | In distribution | |
| AR385011 | In distribution | |
| AR485505 | In distribution | |
| AR436011 | In distribution | |
| FANIHX5010 | In distribution | |
| FALIHX6515 | In distribution | |
| FANIHX4018 | In distribution | |
| AR435513 | In distribution | |
| FALIHX7507 | In distribution | |
| AR385511 | In distribution | |
| AR435018 | In distribution | |
| AR384513 | In distribution | |
| FALIHX7010 | In distribution | |
| AR435505 | In distribution | |
| AR435011 | In distribution | |
| AR435508 | In distribution | |
| FANIHX5513S | In distribution | |
| AR485510 | In distribution | |
| AR485510 | In distribution | |
| AR436015 | In distribution | |
| FALIHX6513 | In distribution | |
| AR435005 | In distribution | |
| AR406010 | In distribution | |
| FANIHX5515 | In distribution | |
| AR385008 | In distribution | |
| AR436011 | In distribution | |
| AR406007 | In distribution | |
| AR385508 | In distribution | |
| AR384513 | In distribution | |
| FANIHX4508 | In distribution | |
| AR485515 | In distribution | |
| AR485513 | In distribution | |
| FANIHX4511 | In distribution | |
| AR435010 | In distribution | |
| AR435508 | In distribution | |
| AR384518 | In distribution | |
| AR485507 | In distribution | |
| AR384518 | In distribution | |
| AR436013 | In distribution | |
| AR385510 | In distribution | |
| FALIHX6511 | In distribution | |
| FANIHX3511 | In distribution | |
| AR435018 | In distribution | |
| FANIHX5013S | In distribution | |
| AR333505 | In distribution | |
| FALIHX6010 | In distribution | |
| FALIHX8008 | In distribution | |
| FALIHX7511 | In distribution | |
| AR435007 | In distribution | |
| AR406011 | In distribution | |
| FALIHX7008 | In distribution | |
| FALIHX6011 | In distribution | |
| AR485508 | In distribution | |
| AR385511 | In distribution | |
| FANIHX5007 | In distribution | |
| AR384508 | In distribution | |
| AR385018 | In distribution | |
| AR436010 | In distribution | |
| AR385015 | In distribution | |
| FANIHX4011 | In distribution | |
| FANIHX5011S | In distribution | |
| AR435010 | In distribution | |
| FALIHX6015 | In distribution | |
| AR436013 | In distribution | |
| FANIHX3518 | In distribution | |
| AR334505 | In distribution | |
| FANIHX5018 | In distribution | |
| FANIHX5510 | In distribution | |
| FANIHX3513 | In distribution | |
| AR406011 | In distribution | |
| FANIHX4507 | In distribution | |
| AR435008 | In distribution | |
| AR385015 | In distribution | |
| AR406007 | In distribution | |
| AR385011 | In distribution | |
| FALIHX7007 | In distribution | |
| AR485511 | In distribution | |
| FANIHX5008S | In distribution | |
| AR406008 | In distribution | |
| FANIHX4010 | In distribution | |
| AR385507 | In distribution | |
| FALIHX6508 | In distribution | |
| AR385513 | In distribution | |
| FANIHX4515 | In distribution | |
| AR485515 | In distribution | |
| FANIHX5508 | In distribution | |
| FALIHX7513 | In distribution | |
| FALIHX8010 | In distribution | |
| FANIHX4518 | In distribution | |
| AR406013 | In distribution | |
| FANIHX5511S | In distribution | |
| FANIHX5513 | In distribution | |
| AR485513 | In distribution | |
| AR435515 | In distribution | |
| FANIHX4008 | In distribution | |
| AR385018 | In distribution | |
| AR385007 | In distribution | |
| AR385518 | In distribution | |
| FALIHX7510 | In distribution | |
| AR435013 | In distribution | |
| FALIHX6013 | In distribution | |
| FANIHX3510 | In distribution | |
| AR406015 | In distribution | |
| AR384511 | In distribution | |
| AR406008 | In distribution | |
| AR436015 | In distribution | |
| AR435518 | In distribution | |
| AR385508 | In distribution | |
| AR384511 | In distribution | |
| FANIHX4015 | In distribution | |
| AR385013 | In distribution | |
| AR435513 | In distribution | |
| FALIHX7015 | In distribution | |
| FALIHX7515 | In distribution | |
| AR384507 | In distribution | |
| AR385505 | In distribution | |
| AR435013 | In distribution | |
| AR384507 | In distribution | |
| FANIHX5010S | In distribution | |
| AR406013 | In distribution | |
| AR435007 | In distribution | |
| FALIHX7013 | In distribution | |
| AR435518 | In distribution | |
| FANIHX5508S | In distribution | |
| AR384510 | In distribution | |
| FANIHX4013 | In distribution | |
| AR385010 | In distribution | |
| AR435507 | In distribution | |
| AR436008 | In distribution | |
| FALIHX8011 | In distribution | |
| AR435008 | In distribution | |
| AR335505 | In distribution | |
| AR485507 | In distribution | |
| FANIHX4510 | In distribution | |
| AR435511 | In distribution | |
| FALIHX8007 | In distribution | |
| AR384515 | In distribution | |
| FANIHX5515S | In distribution | |
| AR384508 | In distribution | |
| AR384510 | In distribution | |
| AR406015 | In distribution | |
| AR485508 | In distribution | |
| AR435510 | In distribution | |
| AR385010 | In distribution | |
| FANIHX5015S | In distribution | |
| AR435510 | In distribution | |
| AR385008 | In distribution | |
| AR385007 | In distribution | |
| AR385507 | In distribution | |
| FANIHX5507 | 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.