ET III Fixture NH Regular [ Implant Only ]

GUDID 00814913024127

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913024127
• NIH Device Record Key: 91619df0-20a5-4578-be7e-fdbd3abbb468
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET III Fixture NH Regular [ Implant Only ]
• Version Model Number: ET3R4511B
• 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	00814913024127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151626

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2016-08-04

On-Brand Devices [ET III Fixture NH Regular [ Implant Only ]]

• 00814913024202: ET3R5015B
• 00814913024196: ET3R5013B
• 00814913024189: ET3R5011B
• 00814913024172: ET3R5010B
• 00814913024165: ET3R5008B
• 00814913024158: ET3R5007B
• 00814913024141: ET3R4515B
• 00814913024134: ET3R4513B
• 00814913024127: ET3R4511B
• 00814913024110: ET3R4510B
• 00814913024103: ET3R4508B
• 00814913024097: ET3R4507B
• 00814913024080: ET3R4015B
• 00814913024073: ET3R4013B
• 00814913024066: ET3R4011B
• 00814913024059: ET3R4010B
• 00814913024042: ET3R4008B
• 00814913024035: ET3R4007B