DIO UF HSA Internal Sub-Merged Implant System UF(II) 4011S

GUDID 08800049224861

The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO UF HSA Internal Sub-Merged Implant System is specially designed for using in dental implant surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.

DIO Corporation

Screw endosteal dental implant, two-piece
Primary Device ID08800049224861
NIH Device Record Keydd50a03e-4517-4af2-86f3-20b41673781d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIO UF HSA Internal Sub-Merged Implant System
Version Model NumberUF(II) 4011S
Catalog NumberUF(II) 4011S
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

Device Dimensions

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Device Size Text, specify0
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Device Size Text, specify0
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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

Device Identifiers

Device Issuing AgencyDevice ID
GS108800049224861 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-09
Device Publish Date2022-03-01

On-Brand Devices [DIO UF HSA Internal Sub-Merged Implant System]

08806195967829ICC 65309N
08806195967812ICC 60649N
08806195967805ICC 48588N
08806195967799ICC 48508N
08806195958926STI 2004
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08806195930311The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
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