ET III Fixture NH Regular No Mount

GUDID 00810126044655

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810126044655
• NIH Device Record Key: cb3dedd6-13a9-4db3-9d50-80bc8cf4ecc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET III Fixture NH Regular No Mount
• Version Model Number: CET3R5006B
• 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	00810126044655 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-07
• Device Publish Date: 2025-09-29

On-Brand Devices [ET III Fixture NH Regular No Mount]

• 00810126044778: CET3R5015B
• 00810126044754: CET3R5013B
• 00810126044730: CET3R5011B
• 00810126044716: CET3R5010B
• 00810126044693: CET3R5008B
• 00810126044679: CET3R5007B
• 00810126044655: CET3R5006B
• 00810126044631: CET3R4515B
• 00810126044617: CET3R4513B
• 00810126044594: CET3R4511B
• 00810126044570: CET3R4510B
• 00810126044556: CET3R4508B
• 00810126044532: CET3R4507B
• 00810126044518: CET3R4015B
• 00810126044495: CET3R4013B
• 00810126044471: CET3R4011B
• 00810126044457: CET3R4010B
• 00810126044433: CET3R4008B
• 00810126044419: CET3R4007B