TITE-FIT/TAPERED TITE-FIT T-AAT

GUDID 07290110727291

TRANSFER

HI-TEC IMPLANTS LTD.

Dental implant system

• Primary Device ID: 07290110727291
• NIH Device Record Key: 0454ad10-2155-4b83-a21e-e561cbe0d3c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TITE-FIT/TAPERED TITE-FIT
• Version Model Number: T-AAT
• Catalog Number: T-AAT
• 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	07290110727291 [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 [TITE-FIT/TAPERED TITE-FIT]

• 07290110728977: ABUTMENT SCREW
• 07290110728960: ABUTMENT SCREW
• 07290110728953: ABUTMENT SCREW
• 07290110727543: ABUTMENT ANALOG
• 07290110727536: ABUTMENT ANALOG
• 07290110727529: ABUTMENT ANALOG
• 07290110727468: IMPLANT ANALOG
• 07290110727451: IMPLANT ANALOG
• 07290110727345: TRANSFER
• 07290110727338: TRANSFER
• 07290110727307: TRANSFER
• 07290110727291: TRANSFER
• 07290110726867: CASTABLE PLASTIC SLEEVE
• 07290110726850: CASTABLE PLASTIC SLEEVE
• 07290110726843: CASTABLE PLASTIC SLEEVE
• 07290110726836: CASTABLE PLASTIC SLEEVE
• 07290110726829: CASTABLE PLASTIC SLEEVE
• 07290110726812: CASTABLE PLASTIC SLEEVE
• 07290110726805: CASTABLE PLASTIC SLEEVE
• 07290110726799: CASTABLE PLASTIC SLEEVE
• 07290110726782: FIXATION SCREW
• 07290110726775: CASTABLE PLASTIC SLEEVE
• 07290110726676: BALL-ATTACHMENT ABUTMENT
• 07290110726669: BALL-ATTACHMENT ABUTMENT
• 07290110726652: BALL-ATTACHMENT ABUTMENT
• 07290110726362: CYLINDER
• 07290110726348: FIXATION SCREW
• 07290110726331: FIXED DETACHABLE ABUTMENT
• 07290110726324: FIXATION SCREW
• 07290110726300: CYLINDER
• 07290110726287: FIXED DETACHABLE ABUTMENT
• 07290110725747: SCAN ABUTMENT
• 07290110725730: SCAN ABUTMENT
• 07290110725563: T-BASE ABUTMENT
• 07290110725556: T-BASE ABUTMENT
• 07290110725235: T-BASE ABUTMENT
• 07290110725228: T-BASE ABUTMENT
• 07290110725068: ZIRCONIUM ABUTMENT
• 07290110724894: CASTABLE ABUTMENT
• 07290110724887: CASTABLE ABUTMENT
• 07290110724573: SCREW-IN ABUTMENT
• 07290110724566: SCREW-IN ABUTMENT
• 07290110724559: SCREW-IN ABUTMENT
• 07290110724528: ANGULATED ABUTMENT
• 07290110724290: ANTI-ROTATION ABUTMENT
• 07290110724283: ANTI-ROTATION ABUTMENT
• 07290110722951: HEALING CAP
• 07290110722944: HEALING CAP
• 07290110722937: HEALING CAP
• 07290110722654: IMPLANT SCREW