Access of eIFU

Manufacturers shall provide information on how to access the instructions for use in electronic form. This information is provided on the product label, packaging for each unit and on the sales packaging.

Manufacturer providing information on the web page and same information listed in eIFU about where, how and within which time instructions for use in paper form can be requested at no cost.

eIFU for ROOTT medical devices does not contain a part of the instructions for use which is intended to be provided to the patient, its for use by professional users only.

eIFU for ROOTT medical devices in electronic form are available entirely as text which contain symbols and graphics with the same information as the instructions for use in paper form. Video files may be offered in addition to the text of the eIFU and mentioned in eIFU as references.

Paper version request information

By the request, provided via email, phone call or post mail, the printed version of the instruction for use will be sent as requested at the latest within 7 calendar days of receiving a request from the user or at the time of delivery of the device if so requested at the time of order.

Email: vladlena.shulezhko@trate.com

Phone: +41798481918

Instructions for use

Click on the links below to view the IFU (Instructions for Use) Documents:

• Instruction for opening boxes and blisters of ROOTT sterile products EN (valid from 2020.11.27) – PL
• Instruction for use Dental Implant System ROOTT Rootform implants EN (valid from 2020.06.25) – PL
• ROOTFORM implant placement protocol EN (valid from 2020.11.27)
• Instruction for use Dental Implant System ROOTT COMPRESSIVE implants (incl. S, M, K, MS, MP) EN (valid from 2020.06.25) – PL
• Instruction for use Dental Implant System ROOTT BASAL implants EN (valid from 2020.06.25) – PL
• Instruction for use Dental Implant System ROOTT Abutments and Gingiva formers EN (valid from 2020.06.25) – PL
• Instruction for use Drills for Dental Implant System ROOTT EN (valid from 2019.04.19) – PL
• Drilling protocol for ROOTFORM Implants EN (valid from 2020.07.02)
• Drilling protocol for COMPRESSIVE Implants EN (valid from 2020.07.02)
• Instruction for cleaning, disinfection and sterilization of non sterile and reusable medical devices Dental Implant System ROOTT EN (valid from 2020.08.31) – PL
• Assemble and dissasemble of the products EN (valid from 2020.07.02)
• Examples of inspection of the defects EN (valid from 2021.05.20)
• Instruction for use Torque wrench (TW50) EN (valid from 2020.02.11) – PL
• Instruction for implant removal EN (valid from 2020.07.02)
• Instruction for Product Return EN (valid from 2020.10.19) – PL
• Biohazardous Implant-related Waste Disposal Instruction for the Dental Offices EN (valid from 2020.10.19) – PL

* Please note that translations are automatically generated for your convenience and may not be accurate. For accurate information refer to the original files.

• Trate System Overview
• Trate Manual
• Trate Order List
• ROOTT Manual for new users
• Trate Drilling Protocol

• Prosthetic ROOTT R-CAD-CAM
• Prosthetic ROOTT R-cement
• Prosthetic ROOTT R-MUA 1
• Prosthetic ROOTT R-MUA 2
• Prosthetic ROOTT R-MUA-S 1
• Prosthetic ROOTT R-MUA-S 2

• Certificate of Registration QMS ISO 13485 2016
• EC Certificate – Full Quality Assurance System
• Free sale certificate by Swiss agency for therapeutic products
• Declaration on chemical composition 

This warranty and return policy applies to all products, produced by TRATE AG. This policy only covers the replacement of products, but not any associated costs and expenses, including but not limited to any associated treatments.

Warranty conditions

TRATE AG hereby guarantees that, if any product is defective as a result of a failure of the material strength and stability of the product during the guarantee period, TRATE will replace the product with the same or substantially equivalent product.

Provided however that the following guarantee conditions are individually and collectively met and documented:

• Warranty duration – lifetime, in case, when will be proven that ROOTT system components were used in accordance with the requirements of the instruction for use and under indications, conditions and contraindications which described by the manufacturer in the instructions for use.
• Products have been used exclusively and not in combination with any other manufacturer’s products
• Warranty case appeared because products were implanted to the patient with absolute / relative contraindications
• No guarantee case resulting from an accident, a trauma or any other damage caused by the patient or a third party
• Providing a request for guaranty not later than three months after a case arises.

Eligibility

To receive warranty benefits, the treating clinician or distributor must:

1. Notify TRATE AG. Notification is accomplished by submission of a properly completed Warranty and Return Form with return of properly cleaned and decontaminated device packed such to prevent damage throughout transportation. Clear procedure for cleaning, decontamination, packaging and labeling for such devices available in Instruction for Product return.
2. Be current in all financial account activities with TRATE AG
3. Be sure that all devices covered by this Warranty Policy installed in accordance with TRATE prescribed procedures, including the IFU, and in accordance with accepted medical / dental practices.

Important! Warranty and Return Form available on the webpage www.trate.com as Annex to the Warranty and Return Policy or you may contact your Customer Service representative. All warranty claim submissions must include the LOT number of all devices. Failure to provide this information or any other required information, or failure to return original devices, may result void of the warranty policy.

Waranty statement for ROOTT implants

Limits and limitations

This warranty policy is the only warranty provided by TRATE AG. TRATE AG hereby disclaims any other warranties, express or implied hereby TRATE excludes any liability for lost earnings and direct or indirect damages as well as collateral and consequential damages, directly and indirectly related to products, services and information.

Guarantee territory

This guarantee applies worldwide to the products manufactured by TRATE AG.

Modification or termination

TRATE may modify or terminate this warranty policy at any time in whole or in part. Changes to or termination of the warranty policy will not affect the warranty given for the products implanted prior to the date of the change or termination.

Product exchange

Not used products can be exchanged (same or greater value) within twelve (12) months of invoice date but must have a minimum six (6) months shelf life.

All items must be in their original packaging, undamaged, unmarked and unopened.

In any case the Warranty and Return Form shall be filled and sent together with the products.

If the product was in use, follow the procedure for cleaning, decontamination, packaging and labeling for such devices available in Instruction for Product return.

Reporting procedure

Distributors / Healthcare professionals / Patients that have received information about suspected incidents related to a TRATE products, shall immediately forward this information to the manufacturer via submission of application in “Contact us” on the webpage www.trate.com or call Customer Service at + 41 79 848 19 18.

• 16391728 VIENATURIAI VS KLASIKA STRAIPSNIS ARTICLE Morta Stasikėlytė
• BJSTR MS ID 001136
• Metals 08 00573
• Publication One piece implants
• Dirk Duddeck | Research
• Henri Diederich | Case Report
• Henri Diederich | Case Report
• Dr. Igor Malinovskiy | Clinical Case Overview
• M.D. Henri Diederich | Rehabilitation
• Henri Diederich | Principles of Cortically Fixed At Once(CF@O)
• D Vadim Klymentiev, Ph.D Prof. Elena Dorosenko, Ph. D Maxim Pavlenko | Report
• D Vadim Klymentiev, Ph.D Prof. Elena Dorosenko, Ph. D Maxim Pavlenko | Report
• Dr. Alvaro Bastida | One Piece Implant Bibliography
• Mohamed El Moheb | Case Report

ROOTT digital libraries

Animations

Photos