Implant Cover Screw BH-CS10

GUDID 07290109741482

Implant Cover Screw

BHI IMPLANTS LTD

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07290109741482
• NIH Device Record Key: e912abfc-0aa1-4f00-899b-9612e0370bd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Implant Cover Screw
• Version Model Number: 1
• Catalog Number: BH-CS10
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109741482 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103280

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[07290109741482]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-07
• Device Publish Date: 2016-06-30

Devices Manufactured by BHI IMPLANTS LTD

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• 07290109747675 - SIN360 ROSEN SMILER IMPLANT DRIVER: 2024-11-28 SIN360 ROSEN SMILER IMPLANT DRIVER
• 07290109747576 - ROSEN SCREW: 2024-06-28 50 X Rosen Screw M1.4 (T5) Long
• 07290109747583 - ROSEN SCREW: 2024-06-28 50 X Wave Rosen Screw M1.4 (T5) Long
• 07290109747590 - ROSEN SCREW: 2024-06-28 50 X Rosen Screw M1.4 (T5)
• 07290109747606 - ROSEN SCREW: 2024-06-28 50 X Wave Rosen Screw M1.4 (T5)
• 07290109747613 - ROSEN SCREW: 2024-06-28 50 X Rosen Screw M1.6 (T5)
• 07290109747620 - ROSEN SCREW: 2024-06-28 50 X Wave Rosen Screw M1.6 (T5)