DIO PROTEM IMPLANT SYSTEM MFB 25212

GUDID 08806195912461

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.

DIO Corporation

Screw endosteal dental implant, two-piece
Primary Device ID08806195912461
NIH Device Record Key8ba12cc7-26d4-45bb-b1d9-694dce24a436
Commercial Distribution Discontinuation2022-02-28
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIO PROTEM IMPLANT SYSTEM
Version Model NumberMFB 25212
Catalog NumberMFB 25212
Company DUNS631085206
Company NameDIO Corporation
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com
Phone213-365-2875
Emailusahq@dioimplantusa.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108806195912461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-02-18
Device Publish Date2015-10-21

On-Brand Devices [DIO PROTEM IMPLANT SYSTEM]

08806195912515DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195912508DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195912492DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195912485DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195912478DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195912461DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195912454DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195912447DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195912430DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195912423DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195912416DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195912409DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195912393DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195912386DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195912379DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195912362DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195911709DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195911686DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195911662DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195911655DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195911631DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195911617DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195911594DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195911587DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195911570DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195911563DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195911556DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195911549DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195911532DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195911525DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195911518DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08806195911501DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049214824DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049214787DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049214749DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049214701DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049214664DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049214626DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049214589DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049214541DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049214527DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049214503DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049214480DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049214466DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049214442DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049214428DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049214404DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049214381DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049213780DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica
08800049213742DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgica

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.