SELF THREAD W-ACA-E-1

GUDID 07290110724016

ANTI-ROTATION ABUTMENT

HI-TEC IMPLANTS LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07290110724016
• NIH Device Record Key: 61cf49b0-ef07-4088-8aac-12aa0f84f9a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SELF THREAD
• Version Model Number: W-ACA-E-1
• Catalog Number: W-ACA-E-1
• 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	07290110724016 [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: 2017-06-08

On-Brand Devices [SELF THREAD ]

• 07290110728243: MODULAR SYSTEM ABUTMENT
• 07290110728236: MODULAR SYSTEM ABUTMENT
• 07290110728229: MODULAR SYSTEM ABUTMENT
• 07290110728212: MODULAR SYSTEM ABUTMENT
• 07290110727680: UNIVERSAL UNIT ANGULATED ABUTMENT
• 07290110727673: UNIVERSAL UNIT ABUTMENT
• 07290110727666: UNIVERSAL UNIT ABUTMENT
• 07290110727659: UNIVERSAL UNIT ABUTMENT
• 07290110727642: UNIVERSAL UNIT ABUTMENT
• 07290110727383: IMPLANT ANALOG
• 07290110727055: TRANSFER
• 07290110727048: TRANSFER
• 07290110727031: TRANSFER
• 07290110727024: TRANSFER
• 07290110726447: BALL-ATTACHMENT ABUTMENT
• 07290110726430: BALL-ATTACHMENT ABUTMENT
• 07290110726423: BALL-ATTACHMENT ABUTMENT
• 07290110726416: BALL-ATTACHMENT ABUTMENT
• 07290110726140: FIXED DETACHABLE ABUTMENT
• 07290110726133: FIXED DETACHABLE ABUTMENT
• 07290110726126: FIXED DETACHABLE ABUTMENT
• 07290110726119: FIXED DETACHABLE ABUTMENT
• 07290110726102: FIXED DETACHABLE ABUTMENT
• 07290110725624: SCAN ABUTMENT
• 07290110725617: SCAN ABUTMENT
• 07290110725440: T-BASE ABUTMENT
• 07290110725433: T-BASE ABUTMENT
• 07290110725273: CAD CAM ABUTMENT
• 07290110725112: T-BASE ABUTMENT
• 07290110725105: T-BASE ABUTMENT
• 07290110724979: ZIRCONIUM ANGULATED ABUTMENT
• 07290110724962: ZIRCONIUM ABUTMENT
• 07290110724955: ZIRCONIUM ABUTMENT
• 07290110724702: CASTABLE ABUTMENT
• 07290110724696: CASTABLE ABUTMENT
• 07290110724689: CASTABLE ABUTMENT
• 07290110724672: CASTABLE ABUTMENT
• 07290110724542: SCREW-IN ABUTMENT
• 07290110724399: ANGULATED ABUTMENT
• 07290110724382: ANGULATED ABUTMENT
• 07290110724375: ANGULATED ABUTMENT
• 07290110724368: ANGULATED ABUTMENT
• 07290110724061: ANTI-ROTATION ABUTMENT
• 07290110724054: ANTI-ROTATION ABUTMENT
• 07290110724047: ANTI-ROTATION ABUTMENT
• 07290110724030: ANTI-ROTATION ABUTMENT
• 07290110724023: ANTI-ROTATION ABUTMENT
• 07290110724016: ANTI-ROTATION ABUTMENT
• 07290110724009: ANTI-ROTATION ABUTMENT
• 07290110722753: HEALING CAP