Shark BH-SH508

GUDID 07290109741628

Dental Implant

BHI IMPLANTS LTD

Basket endosteal dental implant, two-piece

• Primary Device ID: 07290109741628
• NIH Device Record Key: 85a11f94-9d0c-434d-9a5b-e58e9a3c58f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shark
• Version Model Number: 1
• Catalog Number: BH-SH508
• 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: true
• 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

• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109741628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103280

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-16

On-Brand Devices [Shark]

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• 07290109741697: Dental Implant
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• 07290109741666: Dental Implant
• 07290109741659: Dental Implant
• 07290109741642: Dental Implant
• 07290109741635: Dental Implant
• 07290109741628: Dental Implant
• 07290109741611: Dental Implant
• 07290109741604: Dental Implant
• 07290109741598: Dental Implant
• 07290109741581: Dental Implant
• 07290109741574: Dental Implant
• 07290109741567: Dental Implant
• 07290109741550: Dental Implant
• 07290109741543: Dental Implant
• 07290109741536: Dental Implant
• 07290109741529: Dental Implant