ET III NH Ultra-Wide Fixture No Mount

GUDID 00810126045058

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810126045058
• NIH Device Record Key: 10137a92-95a4-4c68-898f-00bd52fc0ec8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET III NH Ultra-Wide Fixture No Mount
• Version Model Number: CET3R7007B
• 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	00810126045058 [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 NH Ultra-Wide Fixture No Mount]

• 00810126045133: CET3R7013B
• 00810126045119: CET3R7011B
• 00810126045096: CET3R7010B
• 00810126045072: CET3R7008B
• 00810126045058: CET3R7007B
• 00810126045034: CET3R7006B
• 00810126045010: CET3R6013B
• 00810126044990: CET3R6011B
• 00810126044976: CET3R6010B
• 00810126044952: CET3R6008B
• 00810126044938: CET3R6007B
• 00810126044914: CET3R6006B