UF(II) Wide UF(II) 6011SF

GUDID 08800049227893

DIO Corporation

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 08800049227893
• NIH Device Record Key: e9dfcb27-36d5-477b-b5cb-2d2b87bfe6ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UF(II) Wide
• Version Model Number: UF(II) 6011SF
• Catalog Number: UF(II) 6011SF
• 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

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	08800049227893 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173975

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: 2022-03-09
• Device Publish Date: 2022-03-01

On-Brand Devices [UF(II) Wide]

• 08806195981849: UF(II) 7013SF
• 08806195981832: UF(II) 7011SF
• 08806195981825: UF(II) 7010SF
• 08806195981818: UF(II) 7008SF
• 08806195981801: UF(II) 7007SF
• 08806195981795: UF(II) 6513SF
• 08806195981788: UF(II) 6511SF
• 08806195981771: UF(II) 6510SF
• 08806195981764: UF(II) 6508SF
• 08806195981757: UF(II) 6507SF
• 08806195981740: UF(II) 6013SF
• 08806195981733: UF(II) 6011SF
• 08806195981726: UF(II) 6010SF
• 08806195981719: UF(II) 6008SF
• 08806195981702: UF(II) 6007SF
• 08806195934579: UF(II) 7013S
• 08806195934562: UF(II) 7011S
• 08806195934555: UF(II) 7010S
• 08806195934548: UF(II) 7008S
• 08806195934531: UF(II) 7007S
• 08806195934500: UF(II) 6513S
• 08806195934494: UF(II) 6511S
• 08806195934487: UF(II) 6510S
• 08806195934470: UF(II) 6508S
• 08806195934463: UF(II) 6507S
• 08806195934432: UF(II) 6013S
• 08806195934425: UF(II) 6011S
• 08806195934418: UF(II) 6010S
• 08806195934401: UF(II) 6008S
• 08806195934395: UF(II) 6007S
• 08800049228920: UF(II) 7013SF
• 08800049228906: UF(II) 7013S
• 08800049228852: UF(II) 7011SF
• 08800049228838: UF(II) 7011S
• 08800049228784: UF(II) 7010SF
• 08800049228760: UF(II) 7010S
• 08800049228715: UF(II) 7008SF
• 08800049228692: UF(II) 7008S
• 08800049228647: UF(II) 7007SF
• 08800049228623: UF(II) 7007S
• 08800049228449: UF(II) 6513SF
• 08800049228425: UF(II) 6513S
• 08800049228371: UF(II) 6511SF
• 08800049228357: UF(II) 6511S
• 08800049228302: UF(II) 6510SF
• 08800049228289: UF(II) 6510S
• 08800049228234: UF(II) 6508SF
• 08800049228210: UF(II) 6508S
• 08800049228166: UF(II) 6507SF
• 08800049228142: UF(II) 6507S