UF(II) Implant System UNSSA 40304

GUDID 08800049273005

TiN coated Solid abutment

DIO Corporation

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800049273005
• NIH Device Record Key: ffea30e4-82e6-4337-95ee-b6cb0a8ae18e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UF(II) Implant System
• Version Model Number: UNSSA 40304
• Catalog Number: UNSSA 40304
• Company DUNS: 631085206
• Company Name: DIO Corporation
• Device Count: 1
• DM Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800049273005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182194

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08800049273005]

Moist Heat or Steam Sterilization

[08800049273005]

Moist Heat or Steam Sterilization

[08800049273005]

Moist Heat or Steam Sterilization

[08800049273005]

Moist Heat or Steam Sterilization

[08800049273005]

Moist Heat or Steam Sterilization

[08800049273005]

Moist Heat or Steam Sterilization

[08800049273005]

Moist Heat or Steam Sterilization

[08800049273005]

Moist Heat or Steam Sterilization

[08800049273005]

Moist Heat or Steam Sterilization

[08800049273005]

Moist Heat or Steam Sterilization

[08800049273005]

Moist Heat or Steam Sterilization

[08800049273005]

Moist Heat or Steam Sterilization

[08800049273005]

Moist Heat or Steam Sterilization

[08800049273005]

Moist Heat or Steam Sterilization

[08800049273005]

Moist Heat or Steam Sterilization

[08800049273005]

Moist Heat or Steam Sterilization

[08800049273005]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-20
• Device Publish Date: 2020-01-10

On-Brand Devices [UF(II) Implant System]

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• 08806195981344: UCA 4802
• 08806195981337: UCA 4801
• 08806195981320: SSCS 3430S
• 08806195981313: SSCS 3420S
• 08806195981306: SSCS 3410S
• 08806195981290: SSCS 3400S
• 08806195977767: DASC 2008H
• 08806195950197: SSSA 75507
• 08806195950180: SSSA 75505
• 08806195950173: SSSA 75504
• 08806195950166: SSSA 75407
• 08806195950159: SSSA 75405
• 08806195950142: SSSA 75404
• 08806195950135: SSSA 75307
• 08806195950128: SSSA 75305
• 08806195950111: SSSA 75304
• 08806195950104: SSSA 75207
• 08806195950098: SSSA 75205
• 08806195950081: SSSA 75204
• 08806195950074: SSSA 75107
• 08806195950067: SSSA 75105
• 08806195950050: SSSA 75104
• 08806195950043: SSSA 65507
• 08806195950036: SSSA 65505
• 08806195950029: SSSA 65504
• 08806195950012: SSSA 65407
• 08806195950005: SSSA 65405
• 08806195949993: SSSA 65404
• 08806195949986: SSSA 65307
• 08806195949979: SSSA 65305
• 08806195949962: SSSA 65304
• 08806195949955: SSSA 65207
• 08806195949948: SSSA 65205
• 08806195949931: SSSA 65204
• 08806195949924: SSSA 65107
• 08806195949917: SSSA 65105
• 08806195949900: SSSA 65104
• 08806195949894: SSSA 55507
• 08806195949887: SSSA 55505
• 08806195949870: SSSA 55504
• 08806195949863: SSSA 55407
• 08806195949856: SSSA 55405
• 08806195949849: SSSA 55404
• 08806195949832: SSSA 55307
• 08806195949825: SSSA 55305
• 08806195949818: SSSA 55304
• 08806195949801: SSSA 55207
• 08806195949795: SSSA 55205
• 08806195949788: SSSA 55204