DIO Protem Implant System
DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgical Instruments. The Protein Implants is an integrated system of endosseous dental implants…
DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgical Instruments. The Protein Implants is an integrated system of endosseous dental implants which designed to protect main implant from immediate loading during osteointegration period, to increase indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sandblasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implants which provide the clinician to maintain the patients’ gingival contour. The Implants have the diameter(2.0/2.5mm) and length.(8/10/12/14mm). The superstructures consist of Protein Cemented Abutment, Ball Cap and Healing Cap. The Protein Cemented Abutments are made of titanium and intended for cement-retained restorations where conventional crown & bridge techniques are required. It can be used for single or multiple unit restorations. Ball Cap intended to retain the O-ring inside of the denture. Healing Cap is fixed on the ball type fixture to protect the direct pressure reduce the motion of fixture. The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation. The implants are gamma sterilized and intended to single use. And the surgical tools are nongamma sterilized and have to be sterilized by user before using.
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) | K080126 |
| Record published | 2022-03-01 |
| Record revised | 2022-02-28 (version 5) |
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 | Storage environment temperature 1 to 30 °C |
| Distribution end date | 2022-02-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MFP 25408 | ® Ø2.5X8mm | In distribution |
| MFB 20414 | ® Ø2.0X14mm | In distribution |
| MFP 20208 | ® Ø2.0X8mm | In distribution |
| MFP 20414 | ® Ø2.0X14mm | In distribution |
| MFB 25212 | ® Ø2.5X12mm | In distribution |
| MFP 20412 | ® Ø2.0X12mm | In distribution |
| MFB 25208 | ® Ø2.5X8mm | In distribution |
| MFP 25212 | ® Ø2.5X12mm | In distribution |
| MFB 20208 | ® Ø2.0X8mm | In distribution |
| MFP 20214 | ® Ø2.0X14mm | In distribution |
| MFP 25414 | ® Ø2.5X14mm | In distribution |
| MFP 20408 | ® Ø2.0X8mm | In distribution |
| MFB 25410 | ® Ø2.5X10mm | In distribution |
| MFB 20212 | ® Ø2.0X12mm | In distribution |
| MFB 25414 | ® Ø2.5X14mm | In distribution |
| MFB 25214 | ® Ø2.5X14mm | In distribution |
| MFP 20212 | ® Ø2.0X12mm | In distribution |
| MFB 25210 | ® Ø2.5X10mm | In distribution |
| MFB 20214 | ® Ø2.0X14mm | In distribution |
| MFB 25408 | ® Ø2.5X8mm | In distribution |
| MFB 20408 | ® Ø2.0X8mm | In distribution |
| MFB 25412 | ® Ø2.5X12mm | In distribution |
| MFP 25412 | ® Ø2.5X12mm | In distribution |
| MFP 20410 | ® Ø2.0X10mm | In distribution |
| MFP 20210 | ® Ø2.0X10mm | In distribution |
| MFP 25214 | ® Ø2.5X14mm | In distribution |
| MFP 25208 | ® Ø2.5X8mm | In distribution |
| MFP 25210 | ® Ø2.5X10mm | In distribution |
| MFB 20210 | ® Ø2.0X10mm | In distribution |
| MFP 25410 | ® Ø2.5X10mm | In distribution |
| MFB 20410 | ® Ø2.0X10mm | In distribution |
| MFB 20412 | ® Ø2.0X12mm | In distribution |
| MFP 20214 | ® Ø2.0X14mm | Withdrawn |
| MFP 25414 | ® Ø2.5X14mm | Withdrawn |
| MFB 25410 | ® Ø2.5X10mm | Withdrawn |
| MFB 20408 | ® Ø2.0X8mm | Withdrawn |
| MFB 20212 | ® Ø2.0X12mm | Withdrawn |
| MFP 25212 | ® Ø2.5X12mm | Withdrawn |
| MFB 20214 | ® Ø2.0X14mm | Withdrawn |
| MFP 20414 | ® Ø2.0X14mm | Withdrawn |
| MFB 25212 | ® Ø2.5X12mm | Withdrawn |
| MFP 25410 | ® Ø2.5X10mm | Withdrawn |
| MFP 25408 | ® Ø2.5X8mm | Withdrawn |
| MFP 25208 | ® Ø2.5X8mm | Withdrawn |
| MFP 25412 | ® Ø2.5X12mm | Withdrawn |
| MFB 25214 | ® Ø2.5X14mm | Withdrawn |
| MFB 20208 | ® Ø2.0X8mm | Withdrawn |
| MFB 25412 | ® Ø2.5X12mm | Withdrawn |
| MFP 25210 | ® Ø2.5X10mm | Withdrawn |
| MFB 20414 | ® Ø2.0X14mm | Withdrawn |
| MFB 20410 | ® Ø2.0X10mm | Withdrawn |
| MFP 20408 | ® Ø2.0X8mm | Withdrawn |
| MFB 25208 | ® Ø2.5X8mm | Withdrawn |
| MFP 20410 | ® Ø2.0X10mm | Withdrawn |
| MFB 25408 | ® Ø2.5X8mm | Withdrawn |
| MFP 20210 | ® Ø2.0X10mm | Withdrawn |
| MFP 20412 | ® Ø2.0X12mm | Withdrawn |
| MFB 20210 | ® Ø2.0X10mm | Withdrawn |
| MFB 20412 | ® Ø2.0X12mm | Withdrawn |
| MFP 20212 | ® Ø2.0X12mm | Withdrawn |
| MFP 20208 | ® Ø2.0X8mm | Withdrawn |
| MFB 25414 | ® Ø2.5X14mm | Withdrawn |
| MFP 25214 | ® Ø2.5X14mm | Withdrawn |
| MFB 25210 | ® Ø2.5X10mm | 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.