EH MONO

GUDID 07290112440334

Harmony One-Piece Dental Implant

ETGAR - MEDICAL INSTRUMENTS LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 07290112440334
• NIH Device Record Key: fc3a3625-962c-4c75-a5e1-d9e781a9c219
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EH MONO
• Version Model Number: EH-3.6-L11.5
• Company DUNS: 514570324
• Company Name: ETGAR - MEDICAL INSTRUMENTS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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	07290112440334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161743

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: 2018-02-26

On-Brand Devices [EH MONO]

• 07290112440396: Harmony One-Piece Dental Implant
• 07290112440389: Harmony One-Piece Dental Implant
• 07290112440372: Harmony One-Piece Dental Implant
• 07290112440365: Harmony One-Piece Dental Implant
• 07290112440358: Harmony One-Piece Dental Implant
• 07290112440341: Harmony One-Piece Dental Implant
• 07290112440334: Harmony One-Piece Dental Implant
• 07290112440327: Harmony One-Piece Dental Implant
• 07290112440310: Harmony One-Piece Dental Implant
• 07290112440303: Harmony One-Piece Dental Implant
• 07290112440297: Harmony One-Piece Dental Implant
• 07290112440280: Harmony One-Piece Dental Implant