ET III Fixture NH Regular Pre-Mounted

GUDID 00814913023595

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913023595
• NIH Device Record Key: 6711cb64-3622-4a29-8d0a-1d93c6b89e9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET III Fixture NH Regular Pre-Mounted
• Version Model Number: AET3R4010B
• 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	00814913023595 [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 Pre-Mounted]

• 00814913023748: AET3R5015B
• 00814913023731: AET3R5013B
• 00814913023724: AET3R5011B
• 00814913023717: AET3R5010B
• 00814913023700: AET3R5008B
• 00814913023694: AET3R5007B
• 00814913023687: AET3R4515B
• 00814913023670: AET3R4513B
• 00814913023663: AET3R4511B
• 00814913023656: AET3R4510B
• 00814913023649: AET3R4508B
• 00814913023632: AET3R4507B
• 00814913023625: AET3R4015B
• 00814913023618: AET3R4013B
• 00814913023601: AET3R4011B
• 00814913023595: AET3R4010B
• 00814913023588: AET3R4008B
• 00814913023571: AET3R4007B
• 00814913029610: AET3R5006B
• 00810126043573: AET3R4507B
• 00810126043542: AET3R4015B
• 00810126043825: AET3R5015B
• 00810126043801: AET3R5013B
• 00810126043788: AET3R5011B
• 00810126043764: AET3R5010B
• 00810126043740: AET3R5008B
• 00810126043726: AET3R5007B
• 00810126043702: AET3R5006B
• 00810126043672: AET3R4515B
• 00810126043658: AET3R4513B
• 00810126043634: AET3R4511B
• 00810126043610: AET3R4510B
• 00810126043597: AET3R4508B
• 00810126043528: AET3R4013B
• 00810126043504: AET3R4011B
• 00810126043481: AET3R4010B