ESI MAX

GUDID 07290112440020

Conical Internal Hex Dental Implant

ETGAR - MEDICAL INSTRUMENTS LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 07290112440020
• NIH Device Record Key: 91dad412-6aa7-4d34-9e37-dba4cec201de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESI MAX
• Version Model Number: ESI-3.3-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	07290112440020 [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 [ESI MAX]

• 07290112440235: Conical Internal Hex Dental Implant
• 07290112440228: Conical Internal Hex Dental Implant
• 07290112440211: Conical Internal Hex Dental Implant
• 07290112440204: Conical Internal Hex Dental Implant
• 07290112440198: Conical Internal Hex Dental Implant
• 07290112440181: Conical Internal Hex Dental Implant
• 07290112440174: Conical Internal Hex Dental Implant
• 07290112440167: Conical Internal Hex Dental Implant
• 07290112440150: Conical Internal Hex Dental Implant
• 07290112440143: Conical Internal Hex Dental Implant
• 07290112440136: Conical Internal Hex Dental Implant
• 07290112440129: Conical Internal Hex Dental Implant
• 07290112440112: Conical Internal Hex Dental Implant
• 07290112440105: Conical Internal Hex Dental Implant
• 07290112440099: Conical Internal Hex Dental Implant
• 07290112440082: Conical Internal Hex Dental Implant
• 07290112440075: Conical Internal Hex Dental Implant
• 07290112440068: Conical Internal Hex Dental Implant
• 07290112440051: Conical Internal Hex Dental Implant
• 07290112440044: Conical Internal Hex Dental Implant
• 07290112440037: Conical Internal Hex Dental Implant
• 07290112440020: Conical Internal Hex Dental Implant
• 07290112440013: Conical Internal Hex Dental Implant
• 07290112440006: Conical Internal Hex Dental Implant