DIO Implant System
The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or…
The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units` prosthetic appliance attachment to restore a patient`s chewing function. The DIO implant system is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used.
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 | DIO Corporation, 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) | K070570 |
| Record published | 2015-09-22 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: tmperature limitation 1˚C ~ 30˚C, Humidity 80% |
| Distribution end date | 2015-09-22 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FTN 4013B | ® Ø4.06X12.6mm | Withdrawn |
| IFI 6514PM | ® Ø6.5X14mm | Withdrawn |
| IFI 6512PM | ® Ø6.5X12mm | Withdrawn |
| PSI 4010P | ® Ø4.0X10mm | Withdrawn |
| PSI 4810 | ® Ø4.8X10mm | Withdrawn |
| IFI 6510PM | ® Ø6.5X10mm | Withdrawn |
| PSI 4010 | ® Ø4.0X10mm | Withdrawn |
| IFI 4012M | ® Ø4.0X12mm | Withdrawn |
| PSI 6514P | ® Ø6.5X14mm | Withdrawn |
| IFI 6508PM | ® Ø6.5X8mm | Withdrawn |
| IFI 4012PM | ® Ø4.0X12mm | Withdrawn |
| PSI 4812 | ® Ø4.8X12mm | Withdrawn |
| PSI 3508P | ® Ø3.5X8mm | Withdrawn |
| FTN 4010B | ® Ø4.06X9.6mm | Withdrawn |
| PSI 4812P | ® Ø4.8X12mm | Withdrawn |
| IFI 3512PM | ® Ø3.5X12mm | Withdrawn |
| FTN 3313B | ® Ø3.3X12.6mm | Withdrawn |
| PSI 4814 | ® Ø4.8X14mm | Withdrawn |
| PSI 4008 | ® Ø4.0X8mm | Withdrawn |
| PSI 4012P | ® Ø4.0X12mm | Withdrawn |
| PSI 4810P | ® Ø4.8X10mm | Withdrawn |
| FTN 3310B | ® Ø3.3X9.6mm | Withdrawn |
| PSI 3512P | ® Ø3.5X12mm | Withdrawn |
| PSI 4808P | ® Ø4.8X8mm | Withdrawn |
| IFI 4008M | ® Ø4.0X8mm | Withdrawn |
| PSI 4008P | ® Ø4.0X8mm | Withdrawn |
| PSI 4014 | ® Ø4.0X14mm | Withdrawn |
| IFI 4010PM | ® Ø4.0X10mm | Withdrawn |
| IFI 4812M | ® Ø4.8X12mm | Withdrawn |
| FTN 5010B | ® Ø4.98X9.6mm | Withdrawn |
| IFI 4014PM | ® Ø4.0X14mm | Withdrawn |
| IFI 4808M | ® Ø4.8X8mm | Withdrawn |
| IFI 4810M | ® Ø4.8X10mm | Withdrawn |
| IFI 4810PM | ® Ø4.8X10mm | Withdrawn |
| IFI 4808PM | ® Ø4.8X8mm | Withdrawn |
| PSI 6510P | ® Ø6.5X10mm | Withdrawn |
| IFI 3510PM | ® Ø3.5X10mm | Withdrawn |
| IFI 3514PM | ® Ø3.5X14mm | Withdrawn |
| PSI 3510P | ® Ø3.5X10mm | Withdrawn |
| PSI 4014P | ® Ø4.0X14mm | Withdrawn |
| PSI 4012 | ® Ø4.0X12mm | Withdrawn |
| PSI 4814P | ® Ø4.8X14mm | Withdrawn |
| FTN 4011B | ® Ø4.06X11.1mm | Withdrawn |
| IFI 4014M | ® Ø4.0X14mm | Withdrawn |
| FTN 5008B | ® Ø4.98X8.1mm | Withdrawn |
| FTN 4015B | ® Ø4.06X14.6mm | Withdrawn |
| PSI 6508P | ® Ø6.5X8mm | Withdrawn |
| PSI 6512P | ® Ø6.5X12mm | Withdrawn |
| IFI 4812PM | ® Ø4.8X12mm | Withdrawn |
| IFI 4008PM | ® Ø4.0X8mm | Withdrawn |
| FTN 3315B | ® Ø3.3X14.6mm | Withdrawn |
| IFI 4814PM | ® Ø4.8X14mm | Withdrawn |
| FTN 3311B | ® Ø3.3X11.1mm | Withdrawn |
| FTN 3308B | ® Ø3.3X8.1mm | Withdrawn |
| PSI 3514P | ® Ø3.5X14mm | Withdrawn |
| FTN 4008B | ® Ø4.06X8.1mm | Withdrawn |
| IFI 4010M | ® Ø4.0X10mm | Withdrawn |
| IFI 3508PM | ® Ø3.5X8mm | Withdrawn |
| PSI 4808 | ® Ø4.8X8mm | Withdrawn |
| FTN 5011B | ® Ø4.98X11.1mm | Withdrawn |
| IFI 4814M | ® Ø4.8X14mm | Withdrawn |
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 |
|---|---|
| K182194 | 2018-12-14 |
| K173975 | 2018-06-01 |
| K170608 | 2018-03-30 |
| K161987 | 2017-02-21 |
| K122519 | 2013-05-21 |
| K112746 | 2011-10-21 |
| K100100 | 2010-11-10 |
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.