ET cover screw Regular

GUDID 00810126041500

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810126041500
• NIH Device Record Key: caf469bd-e0e4-4ec2-9849-f5286361f691
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET cover screw Regular
• Version Model Number: ETCSRS
• 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	00810126041500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140934

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 [ET cover screw Regular]

• 00810126041609: ETCS40S-G
• 00810126041500: ETCSRS