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…

Registry build 21.09.26

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.

7manufacturers in China registered for this device type
64catalogue 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.

Chinese manufacturers registered for FDA product code DZE
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

Regulatory record for DIO Protem Implant System
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

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 numbers for DIO Protem Implant System
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

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

FDA premarket approvals naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer