ET Angled Abutment

GUDID 00810125994098

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810125994098
• NIH Device Record Key: 964af9ce-5c57-42d2-a731-96c7b6dfb19c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET Angled Abutment
• Version Model Number: ETAA4520NC
• 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	00810125994098 [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]

• 00810125994128: ETAA4540NC
• 00810125994111: ETAA4540BC
• 00810125994104: ETAA4540AC
• 00810125994098: ETAA4520NC
• 00810125994081: ETAA4520BC
• 00810125994074: ETAA4520AC
• 00810125994067: ETAA4040MNC
• 00810125994050: ETAA4040MBC
• 00810125994043: ETAA4040MAC
• 00810125994036: ETAA4020MNC
• 00810125994029: ETAA4020MBC
• 00810125994012: ETAA4020MACWH
• 00810125994005: ETAA6040NC
• 00810125993992: ETAA6040BC
• 00810125993985: ETAA6040AC
• 00810125993978: ETAA6020NC
• 00810125993961: ETAA6020BC
• 00810125993954: ETAA6020AC
• 00810125993947: ETAA5040NC
• 00810125993930: ETAA5040BC
• 00810125993923: ETAA5040AC
• 00810125993916: ETAA5020NCWH
• 00810125993909: ETAA5020BC
• 00810125993893: ETAA5020AC
• 00810125993886: ETAA4540MNC
• 00810125993879: ETAA4540MBC
• 00810125993862: ETAA4540MAC
• 00810125993855: ETAA4520MNC
• 00810125993848: ETAA4520MBC
• 00810125993831: ETAA4520MAC