DIO Implant Systems
The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These implants are surgically inserted into the upper and/or lower jawbone, and serve as a…
The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These implants are surgically inserted into the upper and/or lower jawbone, and serve as a substitute or replacement tooth root providing a stable foundation for restorations.
7manufacturers in China registered for this device type
119catalogue numbers in this listing
7510(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 | 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 | 2015-10-17 |
| Record revised | 2022-02-25 (version 4) |
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 |
| Distribution end date | 2022-02-04 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FSN 5513B | ® Ø5.5X13mm | Withdrawn |
| FSN 3311B | ® Ø3.3X11mm | Withdrawn |
| PSI 6512P | ® Ø6.5X12mm | Withdrawn |
| FSN 5510B | ® Ø5.5X10mm | Withdrawn |
| IFI 5512PM | ® Ø5.5X12mm | Withdrawn |
| IFI 4012M | ® Ø4.0X12mm | Withdrawn |
| FSN 3707B | ® Ø3.7X7mm | Withdrawn |
| FSN 4010B | ® Ø4.0X10mm | Withdrawn |
| FSN 5508B | ® Ø5.5X8mm | Withdrawn |
| IFI 4812M | ® Ø4.8X12mm | Withdrawn |
| FSN 4011B | ® Ø4.0X11mm | Withdrawn |
| PSI 4814P | ® Ø4.8X14mm | Withdrawn |
| PSI 3514P | ® Ø3.5X14mm | Withdrawn |
| FSN 5015B | ® Ø5.0X15mm | Withdrawn |
| FTN 4008B | ® Ø4.0X8mm | Withdrawn |
| IFI 5508PM | ® Ø5.5X8mm | Withdrawn |
| PSI 4012 | ® Ø4.0X12mm | Withdrawn |
| PSI 6510P | ® Ø 6.5X10mm | Withdrawn |
| FSN 6011B | ® Ø6.0X11mm | Withdrawn |
| FTN 4011B | ® Ø4.0X11mm | Withdrawn |
| FSN 3708B | ® Ø3.7X8mm | Withdrawn |
| IFI 3508PM | ® Ø3.5X8mm | Withdrawn |
| FSN 5511B | ® Ø5.5X11mm | Withdrawn |
| FSN 5008B | ® Ø5.0X8mm | Withdrawn |
| FSN 3307B | ® Ø3.3X7mm | Withdrawn |
| FTN 4013B | ® Ø4.0X13mm | Withdrawn |
| IFI 3512PM | ® Ø3.5X12mm | Withdrawn |
| IFI 4812PM | ® Ø4.8X12mm | Withdrawn |
| FSN 3715B | ® Ø3.7X15mm | Withdrawn |
| FTN 5508B | ® Ø5.5X8mm | Withdrawn |
| FSN 4008B | ® Ø4.0X8mm | Withdrawn |
| FSN 5013B | ® Ø5.0X13mm | Withdrawn |
| FSN 5010B | ® Ø5.0X10mm | Withdrawn |
| IFI 4008PM | ® Ø4.0X8mm | Withdrawn |
| FSN 5011B | ® Ø5.0X11mm | Withdrawn |
| FTT 5010B | ® Ø5.0X10mm | Withdrawn |
| FTN 3313B | ® Ø3.3X13mm | Withdrawn |
| PSI 4008P | ® Ø4.0X8mm | Withdrawn |
| PSI 4010 | ® Ø4.0X10mm | Withdrawn |
| PSI 4810P | ® Ø4.8X10mm | Withdrawn |
| IFI 6512PM | ® Ø6.5X12mm | Withdrawn |
| PSI 4014P | ® Ø4.0X14mm | Withdrawn |
| FSN 6015B | ® Ø6.0X15mm | Withdrawn |
| FTN 5515B | ® Ø5.5X15mm | Withdrawn |
| FTN 5511B | ® Ø5.5X11mm | Withdrawn |
| FTN 4010B | ® Ø4.0X10mm | Withdrawn |
| IFI 5510PM | ® Ø5.5X10mm | Withdrawn |
| FSN 3710B | ® Ø3.7X10mm | Withdrawn |
| FTT 5015B | ® Ø5.0X15mm | Withdrawn |
| FTN 3308B | ® Ø3.3X8mm | Withdrawn |
| PSI 3510P | ® Ø3.5X10mm | Withdrawn |
| PSI 4012P | ® Ø4.0X12mm | Withdrawn |
| FSN 3308B | ® Ø3.3X8mm | Withdrawn |
| FSN 3315B | ® Ø3.3X15mm | Withdrawn |
| FST 5015B | ® Ø5.0X15mm | Withdrawn |
| FSN 3718B | ® Ø3.7X15mm | Withdrawn |
| FTN 5010B | ® Ø5.0X10mm | Withdrawn |
| PSI 4010P | ® Ø4.0X10mm | Withdrawn |
| IFI 3510PM | ® Ø3.5X10mm | Withdrawn |
| FSN 6008B | ® Ø6.0X8mm | Withdrawn |
| PSI 3508P | ® Ø3.5X8mm | Withdrawn |
| IFI 5514PM | ® Ø5.5X14mm | Withdrawn |
| FSN 6013B | ® Ø6.0X13mm | Withdrawn |
| PSI 4808 | ® Ø4.8X8mm | Withdrawn |
| FTN 5013B | ® Ø5.0X13mm | Withdrawn |
| FST 5011B | ® Ø5.0X11mm | Withdrawn |
| FTN 5513B | ® Ø5.5X13mm | Withdrawn |
| IFI 4810M | ® Ø4.8X10mm | Withdrawn |
| IFI 4814PM | ® Ø4.8X14mm | Withdrawn |
| FST 5010B | ® Ø5.0X10mm | Withdrawn |
| FST 5008B | ® Ø5.0X8mm | Withdrawn |
| FSN 5515B | ® Ø5.5X15mm | Withdrawn |
| IFI 4010M | ® Ø4.0X10mm | Withdrawn |
| IFI 4014PM | ® Ø4.0X14mm | Withdrawn |
| FSN 4007B | ® Ø4.0X7mm | Withdrawn |
| IFI 4810PM | ® Ø4.8X10mm | Withdrawn |
| FTN 5008B | ® Ø5.0X8mm | Withdrawn |
| FSN 3310B | ® Ø3.3X10mm | Withdrawn |
| IFI 4012PM | ® Ø4.0X12mm | Withdrawn |
| FSN 4015B | ® Ø4.0X15mm | Withdrawn |
| FTN 4015B | ® Ø4.0X15mm | Withdrawn |
| PSI 6508P | ® Ø6.5X8mm | Withdrawn |
| FSN 4013B | ® Ø4.0X13mm | Withdrawn |
| FSN 3318B | ® Ø3.3X18mm | Withdrawn |
| IFI 4808M | ® Ø4.8X8mm | Withdrawn |
| PSI 4812P | ® Ø4.8X12mm | Withdrawn |
| FTN 3311B | ® Ø3.3X11mm | Withdrawn |
| FSN 6010B | ® Ø6.0X10mm | Withdrawn |
| FSN 3313B | ® Ø3.3X13mm | Withdrawn |
| FTN 5015B | ® Ø5.0X15mm | Withdrawn |
| IFI 4010PM | ® Ø4.0X10mm | Withdrawn |
| IFI 6508PM | ® Ø6.5X8mm | Withdrawn |
| FTN 3310B | ® Ø3.3X10mm | Withdrawn |
| IFI 4008M | ® Ø4.0X8mm | Withdrawn |
| PSI 4808P | ® Ø4.8X8mm | Withdrawn |
| PSI 4812 | ® Ø4.8X12mm | Withdrawn |
| PSI 6514P | ® Ø6.5X14mm | Withdrawn |
| FST 5013B | ® Ø5.0X13mm | Withdrawn |
| FTN 5510B | ® Ø5.5X10mm | Withdrawn |
| FTT 5013B | ® Ø5.0X13mm | Withdrawn |
| FTT 5008B | ® Ø5.0X8mm | Withdrawn |
| PSI 4810 | ® Ø4.8X10mm | Withdrawn |
| PSI 4014 | ® Ø4.0X14mm | Withdrawn |
| PSI 3512P | ® Ø3.5X12mm | Withdrawn |
| FSN 5007B | ® Ø5.0X7mm | Withdrawn |
| IFI 6510PM | ® Ø6.5X10mm | Withdrawn |
| IFI 4814M | ® Ø4.8X14mm | Withdrawn |
| FSN 3711B | ® Ø3.7X10mm | Withdrawn |
| PSI 4008 | ® Ø4.0X8mm | Withdrawn |
| FTT 5011B | ® Ø5.0X11mm | Withdrawn |
| IFI 4014M | ® Ø4.0X14mm | Withdrawn |
| IFI 4808PM | ® Ø4.8X8mm | Withdrawn |
| FTN 3315B | ® Ø3.3X15mm | Withdrawn |
| IFI 3514PM | ® Ø3.5X14mm | Withdrawn |
| PSI 4814 | ® Ø4.8X14mm | Withdrawn |
| FSN 3713B | ® Ø3.7X13mm | Withdrawn |
| FTN 5011B | ® Ø5.0X11mm | Withdrawn |
| IFI 6514PM | ® Ø6.5X14mm | Withdrawn |
| FSN 4018B | ® Ø4.0X18mm | 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.