ET Hybrid Abutment

GUDID 00814913024813

HIOSSEN, INC.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913024813
• NIH Device Record Key: 03aa7ba9-baf2-42f6-af8b-ace452098b0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET Hybrid Abutment
• Version Model Number: ETCMAMNZS
• 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	00814913024813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170421

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

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: 2018-01-16

On-Brand Devices [ET Hybrid Abutment]

• 00814913024844: ETCMARHZS
• 00814913024837: ETCMARNZS
• 00814913024820: ETCMAMHZS
• 00814913024813: ETCMAMNZS