SIXt BH-C408

GUDID 07290109740317

Dental Implant

BHI IMPLANTS LTD

Basket endosteal dental implant, two-piece

• Primary Device ID: 07290109740317
• NIH Device Record Key: 41f914f4-3749-4b2b-bd4c-a765b496d605
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIXt
• Version Model Number: 1
• Catalog Number: BH-C408
• 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: 4.2 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	07290109740317 [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: 2016-04-12

On-Brand Devices [SIXt]

• 07290109740454: Dental Implant
• 07290109740447: Dental Implant
• 07290109740430: Dental Implant
• 07290109740423: Dental Implant
• 07290109740416: Dental Implant
• 07290109740409: Dental Implant
• 07290109740393: Dental Implant
• 07290109740386: Dental Implant
• 07290109740379: Dental Implant
• 07290109740362: Dental Implant
• 07290109740355: Dental Implant
• 07290109740348: Dental Implant
• 07290109740331: Dental Implant
• 07290109740324: Dental Implant
• 07290109740317: Dental Implant
• 07290109740300: Dental Implant
• 07290109740294: Dental Implant
• 07290109740287: Dental Implant
• 07290109740270: Dental Implant
• 07290109740263: Dental Implant