ET Gold Cast Abutment SET

GUDID 00810125994388

HIOSSEN, INC.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 00810125994388
• NIH Device Record Key: 89c2122a-6678-42f1-9b01-4f438b2dec37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET Gold Cast Abutment SET
• Version Model Number: ETGA4010BCWH
• 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: false
• 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	00810125994388 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222636

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-15
• Device Publish Date: 2024-07-06

On-Brand Devices [ET Gold Cast Abutment SET]

• 00810125994449: ETGA4530BCWH
• 00810125994432: ETGA4530SCWH
• 00810125994425: ETGA4510BCWH
• 00810125994418: ETGA4510SCWH
• 00810125994401: ETGA4030BCWH
• 00810125994395: ETGA4030SCWH
• 00810125994388: ETGA4010BCWH
• 00810125994371: ETGA4010SCWH