ET Custom Healing Abutment

GUDID 00810019240041

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810019240041
• NIH Device Record Key: 29dbe3aa-7ca6-456f-b9a3-8d18fb4064d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET Custom Healing Abutment
• Version Model Number: ETHLAP5R
• 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	00810019240041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161689

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: 2019-05-23
• Device Publish Date: 2019-05-15

On-Brand Devices [ET Custom Healing Abutment ]

• 00810019240065: ETHLAP9R
• 00810019240058: ETHLAP7R
• 00810019240041: ETHLAP5R
• 00810019240027: ETHLAP9M
• 00810019240010: ETHLAP7M
• 00810019240003: ETHLAP5M