NBB External Hex HE35405

GUDID D985HE354050

Healing Dental Implant Abutment

FUSION DENTAL IMPLANTS LLC

Basket endosteal dental implant, two-piece

• Primary Device ID: D985HE354050
• NIH Device Record Key: 7d3f43ae-a7e7-45e5-8377-708939cd6a9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NBB External Hex
• Version Model Number: 3.5 Healing Abutment
• Catalog Number: HE35405
• Company DUNS: 081135800
• Company Name: FUSION DENTAL IMPLANTS LLC
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D985HE354050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K915375

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[D985HE354050]

Moist Heat or Steam Sterilization

[D985HE354050]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-25

On-Brand Devices [NBB External Hex]

• D985HE419060: Lock-Attach Dental Implant Abutment
• D985HE419050: Lock-Attach Dental Implant Abutment
• D985HE419040: Lock-Attach Dental Implant Abutment
• D985HE419030: Lock-Attach Dental Implant Abutment
• D985HE419020: Lock-Attach Dental Implant Abutment
• D985HE419010: Lock-Attach Dental Implant Abutment
• D985HE416100: Provisional Dental Implant Abutment. non engaging
• D985HE416000: Provisional Dental Implant Abutment
• D985HE415500: Dental Implant abutment. non engaging
• D985HE415020: Dental Implant Abutment. Engaging, 10mm
• D985HE415010: Dental Implant Abutment. Engaging 7mm
• D985HE415000: Dental Implant abutment. engaging
• D985HE359050: Lock-Attach Dental Implant Abutment
• D985HE359040: Lock-Attach Dental Implant Abutment
• D985HE359030: Lock-Attach Dental Implant Abutment
• D985HE359020: Lock-Attach Dental Implant Abutment
• D985HE359010: Lock-Attach dental Implant Abutment
• D985HE358030: Multi-unit Dental Implant Abutment
• D985HE358020: Multi-unit Dental Implant Abutment
• D985HE358010: Multi-unit Dental Implant Abutment
• D985HE356000: Dental implant provisional abutment
• D985HE355500: Dental Implant abutment. non engaging
• D985HE355000: Dental Implant abutment. engaging
• D985HE354050: Healing Dental Implant Abutment
• D985HE354030: Healing Dental Implant Abutment
• D985HE352000: Dental Implant Abutment Screw