UF(II) Bar holder abutment MBHCA 4509N

GUDID 08806169097347

The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients.

DIO Corporation

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169097347
• NIH Device Record Key: 1c58bc57-fcbc-47f0-8316-c9059c37e7dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UF(II) Bar holder abutment
• Version Model Number: MBHCA 4509N
• Catalog Number: MBHCA 4509N
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806169097347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193404

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169097347]

Moist Heat or Steam Sterilization

[08806169097347]

Moist Heat or Steam Sterilization

[08806169097347]

Moist Heat or Steam Sterilization

[08806169097347]

Moist Heat or Steam Sterilization

[08806169097347]

Moist Heat or Steam Sterilization

[08806169097347]

Moist Heat or Steam Sterilization

[08806169097347]

Moist Heat or Steam Sterilization

[08806169097347]

Moist Heat or Steam Sterilization

[08806169097347]

Moist Heat or Steam Sterilization

[08806169097347]

Moist Heat or Steam Sterilization

[08806169097347]

Moist Heat or Steam Sterilization

[08806169097347]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-09
• Device Publish Date: 2022-03-01

On-Brand Devices [UF(II) Bar holder abutment]

• 08806169098894: The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with
• 08806169098887: The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with
• 08806169098870: The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with
• 08806169098863: The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with
• 08806169098856: The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with
• 08806169098849: The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with
• 08806169098832: The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with
• 08806169098825: The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with
• 08806169097347: The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with
• 08806169097330: The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with
• 08806169097323: The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with
• 08806169097316: The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with
• 08806169097309: The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with
• 08806169097293: The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with
• 08806169097286: The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with
• 08806169097279: The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with