EK cover screw Middle

GUDID 00810126041685

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810126041685
• NIH Device Record Key: 764e9090-330d-4f87-a306-9e6832650f94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EK cover screw Middle
• Version Model Number: EKCS40M
• Company DUNS: 796083090
• Company Name: HIOSSEN, INC.
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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
GS1	00810126041685 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203360

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-09
• Device Publish Date: 2025-04-01

On-Brand Devices [EK cover screw Middle]

• 00810126041685: EKCS40M
• 00810126041654: EKCS35M