TITE FIT WOI-12

GUDID 07290110721640

DENTAL IMPLANT

HI-TEC IMPLANTS LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 07290110721640
• NIH Device Record Key: aaf87148-7310-4e27-87f2-c00fad1d18d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TITE FIT
• Version Model Number: WOI-12mm
• Catalog Number: WOI-12
• 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	07290110721640 [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 [TITE FIT]

• 07290110721657: DENTAL IMPLANT
• 07290110721640: DENTAL IMPLANT
• 07290110721633: DENTAL IMPLANT
• 07290110721626: DENTAL IMPLANT
• 07290110721619: DENTAL IMPLANT
• 07290110721602: DENTAL IMPLANT
• 07290110721596: DENTAL IMPLANT
• 07290110721589: DENTAL IMPLANT
• 07290110721572: DENTAL IMPLANT
• 07290110721565: DENTAL IMPLANT
• 07290110721558: DENTAL IMPLANT
• 07290110721541: DENTAL IMPLANT
• 07290110721534: DENTAL IMPLANT
• 07290110721527: DENTAL IMPLANT