TRX-TP TRX-TP 3.3-13

GUDID 07290110722135

DENTAL IMPLANT

HI-TEC IMPLANTS LTD.

Screw endosteal dental implant, one-piece

• Primary Device ID: 07290110722135
• NIH Device Record Key: 357b0146-16d6-4bdd-896d-d5b6f0000453
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRX-TP
• Version Model Number: TRX-TP 3.3-13mm
• Catalog Number: TRX-TP 3.3-13
• 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	07290110722135 [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 [TRX-TP]

• 07290110726690: BALL-ATTACHMENT ABUTMENT
• 07290110726683: BALL-ATTACHMENT ABUTMENT
• 07290110726355: FIXED DETACHABLE ABUTMENT
• 07290110724627: SCREW-IN ABUTMENT
• 07290110722135: DENTAL IMPLANT
• 07290110722128: DENTAL IMPLANT
• 07290110722111: DENTAL IMPLANT
• 07290110722104: DENTAL IMPLANT
• 07290110722098: DENTAL IMPLANT
• 07290110722081: DENTAL IMPLANT
• 07290110722074: DENTAL IMPLANT
• 07290110722067: DENTAL IMPLANT