Instructions for use
ROOTT dental implant system

ROOTT dental implant treatment system is conditional with the ECRS method, created in collaboration with the Open Dental Community, which sets higher standards and functionality in professional dentistry through consistent growth of experience and trust.

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.

eIFU files are presented in *.pdf file format which can be opened
and viewed in all modern web browsers and any computer using freely available software
such as Adobe Acrobat Reader, Foxit Reader or other.

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: [email protected]

Phone: +41 79 848 19 18

Instructions for use for MDR products

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

• IFU for ROOTT R implants (valid from 2022 12 05)

• IFU for ROOTT C, CS, B, BS implants (valid from 2022 12 05)

• IFU for ROOTT M, P, S implants (valid from 2022 12 05)

• IFU for ROOTT K implants (valid from 2022 12 05)

• IFU for Abutments (valid from 2022 12 05)

• IFU for Healing abutments (valid from 2022 12 05)

• IFU for Drills (valid from 2022 12 05)

• IFU for Reusable surgical instruments (valid from 2022 12 05)

• Instruction for cleaning, disinfection and sterilization of non-sterile and reusable devices (valid from 2022 12 05)

• IFU for tools related to implantation procedure (valid from 2022 12 05)

• IFU for instruments for handpieces (valid from 2022 12 05)

Compatibility books

• For ROOTT R (valid from 2022 08 24)

• For ROOTT C/CS (valid from 2022 08 24)

• For ROOTT B/BS (valid from 2022 08 24)

• For ROOTT M/P (valid from 2022 08 24)

• For ROOTT S (valid from 2022 08 24)

• For ROOTT K (valid from 2022 08 24)

Drilling protocols

• Drilling protocol R (valid from 2022 10 06)

• Drilling protocol C/CS (valid from 2022 08 24)

• Drilling protocol M/S (valid from 2022 08 24)

• Drilling protocol P (valid from 2022 08 24)

• Drilling protocol B/BS (valid from 2022 08 24)

• Drilling protocol K (valid from 2022 08 24)

Placement protocols

• Placement protocol for R (valid from 2022 10 07)

• Placement protocol for C/CS (valid from 2022 08 24)

• Placement protocol for B/BS (valid from 2022 08 24)

• Placement protocol for M/P (valid from 2022 08 24)

• Placement protocol for S (valid from 2022 08 24)

Instruction manuals

• TRS Instruction manual

• TRS-mini Instruction manual

• DW Instruction manual

ROOTT Product Labelling

• Explanation of Symbols on ROOTT Product Labelling

Instructions for use for MDD products

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 2022.04.01)

• Instruction for opening boxes and blisters of all ROOTT non sterile products EN (valid from 2020.11.27)

• Instruction for use Dental Implant System ROOTT Rootform implants EN (valid from 2020.06.25)

• ROOTT R implant placement protocol EN (valid from 2022.04.01)

• Instruction for use Dental Implant System ROOTT COMPRESSIVE implants (incl. S, M, K, MS, MP) EN (valid from 2020.06.25)

• ROOTT C/CS implant placement protocol EN (valid from 2022.04.01)

• ROOTT M/P implant placement protocol EN (valid from 2021.10.12)

• ROOTT S implant placement protocol EN (valid from 2021.10.12)

• Instruction for use Dental Implant System ROOTT BASAL implants EN (valid from 2020.06.25)

• ROOTT B/BS implant placement protocol EN (valid from 2021.10.12)

• Instruction for use Dental Implant System ROOTT Abutments and Gingiva formers EN (valid from 2020.06.25)

  LT

• Instruction for use Drills for Dental Implant System ROOTT EN (valid from 2019.04.19)

  LT

• Drilling protocol for ROOTT R implants EN (valid from 2021.11.08)

• Drilling protocol for ROOTT C/CS implants EN (valid from 2021.11.08)

• Drilling protocol for ROOTT M/S implants EN (valid from 2021.11.08)

• Instruction for cleaning, disinfection and sterilization of non-sterile and reusable medical devices Dental Implant System ROOTT EN (valid from 2021.05.25)

• Assemble and dissasemble of the products EN (valid from 2022.06.06)

• Examples of inspection of the defects EN (valid from 2022.05.19)

• Instruction for use Torque wrench (TW50) EN (valid from 2020.10.26)

• Instruction for implant removal EN (valid from 2020.07.02)

• Instruction for Product Return EN (valid from 2020.10.19)

• Biohazardous Implant-related Waste Disposal Instruction for the Dental Offices EN (valid from 2020.10.19)

• MRI Safety Information (valid from 2022.03.01)

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

Product Compatibility Books

• Compatibility book ROOTT R

• Compatibility book ROOTT C

• Compatibility book ROOTT B/BS

• Compatibility book ROOTT M/P

• Compatibility book ROOTT S

• Compatibility book ROOTT K

ROOTT Product Labelling

• Explanation of Symbols on ROOTT Product Labelling (valid from 2021.05.21)

Old Versions

• IFU for ROOTT R implants (2022 08 24)

• IFU for ROOTT C, CS, B, BS implants (2022 08 24 – 2022 12 04)

• IFU for ROOTT M, P, S implants (2022 08 24 – 2022 12 04)

• IFU for ROOTT K implants (2022 08 24 – 2022 12 04)

• IFU for Abutments (2022 08 24 – 2022 12 04)

• IFU for Healing abutments (2022 08 24 – 2022 12 04)

• IFU for Drills (2022 08 24 – 2022 12 04)

• IFU for Reusable surgical instruments (2022 08 24 – 2022 12 04)

• Instruction for cleaning, disinfection and sterilization of non-sterile and reusable devices (2022 08 24 – 2022 12 04)

• IFU for tools related to implantation procedure (2022 08 24 – 2022 12 04)

• IFU for instruments for handpieces (2022 08 24 – 2022 12 04)

• Placement protocol for R (2022.08.24 – 2022.10.06)

• Drilling protocol R (2022.08.24 – 2022.10.06)

• Assemble and dissasemble of the products EN (2020.07.02 – 2022.06.05)

• Examples of inspection of the defects EN (2021.05.20 – 2022.05.18)

• ROOTT C/CS implant placement protocol EN (2021.10.12 – 2022.04.01)

• ROOTT R implant placement protocol EN (2021.10.12 – 2022.04.01)

• Instruction for opening boxes and blisters of ROOTT sterile products EN (2020.11.27 – 2022.04.01)

• Drilling protocol for ROOTFORM Implants EN (2020.07.02 – 2021.11.08)

• Drilling protocol for COMPRESSIVE Implants EN (2020.07.02 – 2021.11.08)

• ROOTFORM implant placement protocol EN (2020.11.27-2021.10.12)

• Instruction for cleaning, disinfection and sterilization of non sterile and reusable medical devices Dental Implant System ROOTT (2020.08.31-2021.05.25)

• Instruction for cleaning, disinfection and sterilization of non sterile and reusable medical devices (2020.06.25-2020.08.31)

• Instruction for opening boxes and blisters of sterile products EN (valid from 2020.10.16-2020.11.27)

• Instruction for opening boxes and blisters of sterile products EN (2020.07.02-2020.10.16)

• Instruction for use for basal implants (2019.04.19 – 2020.06.24)

• Instruction for use for basal implants (2019.02.18 – 2019.04.18)

• Instruction for use for compressive implants (2019.08.09 – 2020.06.24)

• Instruction for use for compressive implants (2019.02.18 – 2019.08.08)

• Instruction for use for rootform implants (2019.04.19 – 2020.06.24)

• Instruction for use for root form implants (2019.02.18 – 2019.04.18)

• IFU for Dental Implant System ROOTT (2015.07.13 – 2019.02.17)

• Instructions for use for ROOTT Superstructures (2013.02.04 – 2019.02.17)

• Instruction for use for abutments and gingiva formers (2019.04.19 – 2020.06.24)

• Instruction for use for drills (2019.02.18 – 2019.04.18)

• General application and safety instructions for the medical device produced by TRATE AG (2013.10.01 – 2019.02.17)

• General application and safety instructions for the medical device produced by TRATE AG (2019.02.18 – 2019.04.18)

• Instruction for use for reusable devices (2019.02.18 – 2019.04.18)

• Instruction for cleaning, disinfection and sterilization of non sterile and reusable medical devices (2020.01.31 – 2020.06.24)

• Instructions for the reprocessing (Cleaning, disinfecting and sterilizing) of medical devices produced by TRATE AG (2013.10.01 – 2019.04.19)

• Instruction for cleaning, disinfection and sterilization of non sterile and reusable medical devices (2019.04.19 – 2020.01.31)

• Instruction for use Torque wrench (2018.07.12 – 2020.02.10)