SM-Extra Wide Implant System MX 6410

GUDID 08806195926376

SM-Extra Wide(RBM) Implant System consists of SM-Extra Wide(RBM) fixtures, abutments,prosthetics and surgical instruments. SM-Extra Wide(RBM) Implant Fixtures are made of commercial pure titanium, grade 4 which have a sand-blasted, RBM(Resorbable Blast Media) treated surface. These fixtures are the onestage implant and two-stage implant and surgically inserted in the maxillary or mandibular molar areas or where smaller implants have failed. These fixtures are the integrated system of endosseous dental implants which designed to Provide prosthetics support for dental restoration (Crown, Bridges, and overdentures) in partially or fully edentulous individuals. The screw, cemented and overdenture retained restoration, other superstructure and instruments for prosthetics that used when the SM-Extra Wide implants is surged are same with each standard type of DIO SM Implant System.

DIO Corporation

Screw endosteal dental implant, two-piece
Primary Device ID08806195926376
NIH Device Record Keye50840f2-0ec8-47e6-be76-5f35a1a60eec
Commercial Distribution Discontinuation2022-02-04
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSM-Extra Wide Implant System
Version Model NumberMX 6410
Catalog NumberMX 6410
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS108806195926376 [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 Date2022-02-25
Device Publish Date2015-10-22

On-Brand Devices [SM-Extra Wide Implant System ]

08806195926406SM-Extra Wide(RBM) Implant System consists of SM-Extra Wide(RBM) fixtures, abutments,prosthetics
08806195926390SM-Extra Wide(RBM) Implant System consists of SM-Extra Wide(RBM) fixtures, abutments,prosthetics
08806195926383SM-Extra Wide(RBM) Implant System consists of SM-Extra Wide(RBM) fixtures, abutments,prosthetics
08806195926376SM-Extra Wide(RBM) Implant System consists of SM-Extra Wide(RBM) fixtures, abutments,prosthetics
08806195926369SM-Extra Wide(RBM) Implant System consists of SM-Extra Wide(RBM) fixtures, abutments,prosthetics
08806195926352SM-Extra Wide(RBM) Implant System consists of SM-Extra Wide(RBM) fixtures, abutments,prosthetics
08806195926345SM-Extra Wide(RBM) Implant System consists of SM-Extra Wide(RBM) fixtures, abutments,prosthetics
08806195926338SM-Extra Wide(RBM) Implant System consists of SM-Extra Wide(RBM) fixtures, abutments,prosthetics
08806195926321SM-Extra Wide(RBM) Implant System consists of SM-Extra Wide(RBM) fixtures, abutments,prosthetics
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