ET Healing Abutment

GUDID 00814913023458

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913023458
• NIH Device Record Key: 8c83d985-b0ed-45a5-992c-368d8d7582c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET Healing Abutment
• Version Model Number: ETHLA7004R
• 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	00814913023458 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-08

On-Brand Devices [ET Healing Abutment]

• 00814913023472: ETHLA7007R
• 00814913023465: ETHLA7005R
• 00814913023458: ETHLA7004R
• 00814913023441: ETHLA7003R
• 00814913023434: ETHLA6007R
• 00814913023427: ETHLA6005R
• 00814913023410: ETHLA6004R
• 00814913023403: ETHLA6003R
• 00814913023397: ETHLA5007R
• 00814913023380: ETHLA5005R
• 00814913023373: ETHLA5004R
• 00814913023366: ETHLA5003R
• 00814913023359: ETHLA4507R
• 00814913023342: ETHLA4507M
• 00814913023335: ETHLA4505R
• 00814913023328: ETHLA4505M
• 00814913023311: ETHLA4504R
• 00814913023304: ETHLA4504M
• 00814913023298: ETHLA4503R
• 00814913023281: ETHLA4503M
• 00814913023274: ETHLA4007R
• 00814913023267: ETHLA4007M
• 00814913023250: ETHLA4005R
• 00814913023243: ETHLA4005M
• 00814913023236: ETHLA4004R
• 00814913023229: ETHLA4004M
• 00814913023212: ETHLA4003R
• 00814913023205: ETHLA4003M