UF Implant System UF 5007S

GUDID 08800049400456

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 Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

Primary Device ID	08800049400456
NIH Device Record Key	9f88d962-5be5-43d5-8a3d-6bb6d9fcc2e4
Commercial Distribution Status	In Commercial Distribution
Brand Name	UF Implant System
Version Model Number	UF 5007S
Catalog Number	UF 5007S
Company DUNS	631085206
Company Name	DIO Corporation
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com
Phone	213-365-2875
Email	usahq@dioimplantusa.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08800049400456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K122519

FDA Product Code

DZE	Implant, Endosseous, Root-Form

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-05-19
Device Publish Date	2021-05-11

On-Brand Devices [UF Implant System]

18806195934378	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934361	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934354	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934347	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934330	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934323	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934248	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934231	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934224	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934217	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934200	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934194	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934187	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934170	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934163	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934156	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934149	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934132	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934125	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934118	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195934101	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930349	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930332	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930325	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930318	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930301	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930295	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930288	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930271	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930264	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930257	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930141	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930134	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930127	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930110	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930103	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930097	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930080	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930073	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930066	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930059	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930042	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930035	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930028	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930011	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195930004	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195929992	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195929985	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195929978	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
18806195929961	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur