EXPERT NPX 3.5-10

GUDID 07290110721084

DENTAL IMPLANT

HI-TEC IMPLANTS LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 07290110721084
• NIH Device Record Key: 7fcf6f81-4dd8-4b32-934c-5bed50aaeac2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPERT
• Version Model Number: NPX 3.5-10mm
• Catalog Number: NPX 3.5-10
• 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	07290110721084 [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 [EXPERT]

• 07290110721213: DENTAL IMPLANT
• 07290110721206: DENTAL IMPLANT
• 07290110721190: DENTAL IMPLANT
• 07290110721183: DENTAL IMPLANT
• 07290110721176: DENTAL IMPLANT
• 07290110721169: DENTAL IMPLANT
• 07290110721152: DENTAL IMPLANT
• 07290110721145: DENTAL IMPLANT
• 07290110721138: DENTAL IMPLANT
• 07290110721121: DENTAL IMPLANT
• 07290110721114: DENTAL IMPLANT
• 07290110721107: DENTAL IMPLANT
• 07290110721091: DENTAL IMPLANT
• 07290110721084: DENTAL IMPLANT
• 07290110721077: DENTAL IMPLANT