TITE-FIT WIDE/TAPERED TITE-FIT WIDE TW-PRN-R

GUDID 07290110725587

T-BASE ABUTMENT

HI-TEC IMPLANTS LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07290110725587
• NIH Device Record Key: 5b5dd821-3e69-428b-bf3b-c5cad0f0eda2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TITE-FIT WIDE/TAPERED TITE-FIT WIDE
• Version Model Number: TW-PRN-R
• Catalog Number: TW-PRN-R
• 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	07290110725587 [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: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-06-11

On-Brand Devices [TITE-FIT WIDE/TAPERED TITE-FIT WIDE]

• 07290110728984: ABUTMENT SCREW
• 07290110727574: ABUTMENT ANALOG
• 07290110727567: ABUTMENT ANALOG
• 07290110727550: ABUTMENT ANALOG
• 07290110727321: TRANSFER
• 07290110727314: TRANSFER
• 07290110726317: CYLINDER
• 07290110726294: FIXED DETACHABLE ABUTMENT
• 07290110725761: SCAN ABUTMENT
• 07290110725754: SCAN ABUTMENT
• 07290110725587: T-BASE ABUTMENT
• 07290110725570: T-BASE ABUTMENT
• 07290110725259: T-BASE ABUTMENT
• 07290110725242: T-BASE ABUTMENT
• 07290110725075: ZIRCONIUM ABUTMENT
• 07290110724917: CASTABLE ABUTMENT
• 07290110724900: CASTABLE ABUTMENT
• 07290110724603: SCREW-IN ABUTMENT
• 07290110724597: SCREW-IN ABUTMENT
• 07290110724580: SCREW-IN ABUTMENT
• 07290110724313: ANTI-ROTATION ABUTMENT
• 07290110724306: ANTI-ROTATION ABUTMENT
• 07290110722982: HEALING CAP
• 07290110722975: HEALING CAP
• 07290110722968: HEALING CAP
• 07290110722661: IMPLANT SCREW