ET III NH Ultra-Wide Fixture Pre-Mount

GUDID 00814913025216

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913025216
• NIH Device Record Key: b4032e61-fe13-46d1-a48b-36b5e7db3f76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET III NH Ultra-Wide Fixture Pre-Mount
• Version Model Number: AET3R6008B
• 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	00814913025216 [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: 2019-03-11
• Device Publish Date: 2019-02-28

On-Brand Devices [ET III NH Ultra-Wide Fixture Pre-Mount]

• 00814913025308: AET3R7013B
• 00814913025292: AET3R7011B
• 00814913025285: AET3R7010B
• 00814913025278: AET3R7008B
• 00814913025261: AET3R7007B
• 00814913025254: AET3R7006B
• 00814913025247: AET3R6013B
• 00814913025230: AET3R6011B
• 00814913025223: AET3R6010B
• 00814913025216: AET3R6008B
• 00814913025209: AET3R6007B
• 00814913025193: AET3R6006B