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 Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed 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