UFIII Fixture

GUDID 08800049453155

DIO Corporation

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• Primary Device ID: 08800049453155
• NIH Device Record Key: 5bb90e1c-968e-495b-bc73-4a17efe8319f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UFIII Fixture
• Version Model Number: UFIII 5011UV3
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800049453155 [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: 2023-09-04
• Device Publish Date: 2023-08-25

On-Brand Devices [UFIII Fixture]

• 08800049453179: UFIII 3807S
• 08800049452615: UFIII 3811S
• 08800049452608: UFIII 3810S
• 08800049452592: UFIII 3808S
• 08800049453193: UFIII 3815S
• 08800049452646: UFIII 4008S
• 08800049452639: UFIII 4007S
• 08800049452622: UFIII 3813S
• 08800049453339: UFIII 5016S
• 08800049453315: UFIII 5015S
• 08800049453292: UFIII 4516S
• 08800049453278: UFIII 4515S
• 08800049453254: UFIII 4016S
• 08800049453230: UFIII 4015S
• 08800049453162: UFIII 5013UV3
• 08800049453155: UFIII 5011UV3
• 08800049453148: UFIII 5010UV3
• 08800049453131: UFIII 5008UV3
• 08800049453124: UFIII 5007UV3
• 08800049453117: UFIII 4513UV3
• 08800049453100: UFIII 4511UV3
• 08800049453094: UFIII 4510UV3
• 08800049453087: UFIII 4508UV3
• 08800049453070: UFIII 4507UV3
• 08800049453063: UFIII 4013UV3
• 08800049453056: UFIII 4011UV3
• 08800049453049: UFIII 4010UV3
• 08800049453032: UFIII 4008UV3
• 08800049453025: UFIII 4007UV3
• 08800049453018: UFIII 3813UV3
• 08800049453001: UFIII 3811UV3
• 08800049452998: UFIII 3810UV3
• 08800049452981: UFIII 3808UV3
• 08800049452776: UFIII 5013S
• 08800049452769: UFIII 5011S
• 08800049452752: UFIII 5010S
• 08800049452745: UFIII 5008S
• 08800049452738: UFIII 5007S
• 08800049452721: UFIII 4513S
• 08800049452714: UFIII 4511S
• 08800049452707: UFIII 4510S
• 08800049452691: UFIII 4508S
• 08800049452684: UFIII 4507S
• 08800049452677: UFIII 4013S
• 08800049452660: UFIII 4011S
• 08800049452653: UFIII 4010S