ET Angled Abutment Set

GUDID 00810125993794

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810125993794
• NIH Device Record Key: b3afb7c9-3334-4667-aef2-2e632f782b8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET Angled Abutment Set
• Version Model Number: ETAA4520NCWH
• 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	00810125993794 [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: 2024-07-05

On-Brand Devices [ET Angled Abutment Set]

• 00810125993824: ETAA4540NCWH
• 00810125993817: ETAA4540BCWH
• 00810125993800: ETAA4540ACWH
• 00810125993794: ETAA4520NCWH
• 00810125993787: ETAA4520BCWH
• 00810125993770: ETAA4520ACWH
• 00810125993756: ETAA4040MBCWH
• 00810125993749: ETAA4040MACWH
• 00810125993732: ETAA4020MNCWH
• 00810125993725: ETAA4020MBCWH
• 00810125993718: ETAA4020MACWH
• 00810125993701: ETAA6040NCWH
• 00810125993695: ETAA6040BCWH
• 00810125993688: ETAA6040ACWH
• 00810125993671: ETAA6020NCWH
• 00810125993664: ETAA6020BCWH
• 00810125993657: ETAA6020ACWH
• 00810125993640: ETAA5040NCWH
• 00810125993633: ETAA5040BCWH
• 00810125993626: ETAA5040ACWH
• 00810125993619: ETAA5020NCWH
• 00810125993602: ETAA5020BCWH
• 00810125993596: ETAA5020ACWH
• 00810125993589: ETAA4540MNCWH
• 00810125993572: ETAA4540MBCWH
• 00810125993565: ETAA4540MACWH
• 00810125993558: ETAA4520MNCWH
• 00810125993541: ETAA4520MBCWH
• 00810125993534: ETAA4520MACWH