TRX X-AAT-L

GUDID 07290110727369

TRANSFER

HI-TEC IMPLANTS LTD.

Dental implant system

• Primary Device ID: 07290110727369
• NIH Device Record Key: 8ecd9129-8b91-4ade-966f-3f498b6ff8ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRX
• Version Model Number: X-AAT-L
• Catalog Number: X-AAT-L
• 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: false
• 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	07290110727369 [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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-13

On-Brand Devices [TRX]

• 07290110727475: IMPLANT ANALOG
• 07290110727369: TRANSFER
• 07290110727352: TRANSFER
• 07290110726911: FIXATION SCREW
• 07290110726904: CASTABLE PLASTIC SLEEVE
• 07290110726898: CASTABLE PLASTIC SLEEVE
• 07290110726881: CASTABLE PLASTIC SLEEVE
• 07290110726874: CASTABLE PLASTIC SLEEVE
• 07290110726706: BALL-ATTACHMENT ABUTMENT
• 07290110724610: SCREW-IN ABUTMENT
• 07290110722999: HEALING CAP
• 07290110721954: DENTAL IMPLANT
• 07290110721947: DENTAL IMPLANT
• 07290110721930: DENTAL IMPLANT
• 07290110721923: DENTAL IMPLANT