DIO UF HSA Internal Sub-Merged Implant System

GUDID 08800049453216

DIO Corporation

Screw endosteal dental implant, two-piece

Primary Device ID	08800049453216
NIH Device Record Key	c6498fd9-b7df-448f-8bcb-a711bb53de1c
Commercial Distribution Status	In Commercial Distribution
Brand Name	DIO UF HSA Internal Sub-Merged Implant System
Version Model Number	UFIII 3816S
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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08800049453216 [Primary]
GS1	08806195930113 [Previous]

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	2023-08-30
Device Publish Date	2023-08-22

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

08806195967829	ICC 65309N
08806195967812	ICC 60649N
08806195967805	ICC 48588N
08806195967799	ICC 48508N
08806195958926	STI 2004
08806195930090	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195930083	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195930076	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195930069	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195930052	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195930038	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195930021	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195930014	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195930007	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195929995	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195929988	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195929964	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195929957	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195929940	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195929933	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195929919	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195929902	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195929896	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195929889	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08800049400067	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934371	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934364	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934357	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934340	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934333	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934326	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934241	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934234	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934227	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934210	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934203	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934197	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934180	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934173	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934166	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934159	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934142	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934135	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934128	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934111	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195934104	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195930342	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195930335	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195930328	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
08806195930311	The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur