IMPLEX MPI 3.5-16

GUDID 07290110720964

DENTAL IMPLANT

HI-TEC IMPLANTS LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 07290110720964
• NIH Device Record Key: a9c395a3-0b1f-4300-8877-b27d6526a0b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPLEX
• Version Model Number: MPI 3.5-16mm
• Catalog Number: MPI 3.5-16
• Company DUNS: 600710917
• Company Name: HI-TEC IMPLANTS LTD.
• 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: 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	07290110720964 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941575

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: 2017-05-22

On-Brand Devices [IMPLEX]

• 07290110721060: DENTAL IMPLANT
• 07290110721053: DENTAL IMPLANT
• 07290110721046: DENTAL IMPLANT
• 07290110721039: DENTAL IMPLANT
• 07290110721022: DENTAL IMPLANT
• 07290110721015: DENTAL IMPLANT
• 07290110721008: DENTAL IMPLANT
• 07290110720995: DENTAL IMPLANT
• 07290110720988: DENTAL IMPLANT
• 07290110720971: DENTAL IMPLANT
• 07290110720964: DENTAL IMPLANT
• 07290110720957: DENTAL IMPLANT
• 07290110720940: DENTAL IMPLANT
• 07290110720933: DENTAL IMPLANT
• 07290110720926: DENTAL IMPLANT