Shoulder Abutment BH-SAR2

GUDID 07290109740515

Shoulder Abutment 9.5mm

BHI IMPLANTS LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07290109740515
• NIH Device Record Key: fcd61255-7a80-4e74-8673-07d944150907
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Abutment
• Version Model Number: 1
• Catalog Number: BH-SAR2
• Company DUNS: 600330916
• Company Name: BHI IMPLANTS LTD
• 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: false
• 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

Customer Support Contacts

• Phone: +972046094458
• Email: info@bh-implants.com

Device Dimensions

• Length: 9.5 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109740515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103280

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[07290109740515]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-06-30

On-Brand Devices [Shoulder Abutment ]

• 07290109740539: Shoulder Abutment 11.5mm
• 07290109740522: Shoulder Abutment 10.5mm
• 07290109740515: Shoulder Abutment 9.5mm
• 07290109740508: Shoulder Abutment 8.5mm
• 07290109742564: Shoulder Abutment 9.5mm
• 07290109742830: Shoulder Abutment 10.5mm