13. Please note
Practitioners must have appropriate knowledge
and instruction in the handling of the Straumann
product described herein ("Straumann Product")
for using the Straumann Product safely and prop-
erly in accordance with these instructions for use.
The Straumann Product must be used in accor-
dance with the instructions for use provided by
the manufacturer. It is the practitioner's respon-
sibility to use the device in accordance with these
instructions for use and to determine, if the device
fits to the individual patient situation.
The Straumann Product is part of an overall con-
cept and must be used only in conjunction with
the corresponding original components and in-
struments distributed by Institut Straumann
AG, its ultimate parent company and all affil-
iates or subsidiaries of such parent company
("Straumann"), except if stated otherwise in these
instructions for use. If use of products made by
third parties is not recommended by Straumann
in these instructions for use, any such use will
void any warranty or other obligation, express or
implied, of Straumann.
14. Validity
Upon publication of these instructions for use, all
previous versions are superseded.
© Institut Straumann AG, 2018. All rights reserved.
Straumann® and/or other trademarks and logos
from Straumann® mentioned herein are the trade-
marks or registered trademarks of Straumann
Holding AG and/or its affiliates.
15. Availability
Some items of the Straumann® Dental Implant
System are not available in all countries.
16. Symbols
The following table describes the Symbols that
may be printed on the packaging label.
Please refer to the packaging label for the appli-
cable symbols related to the product.
Symbol
Symbol Description
Consult instructions
for use. Please follow
the link to the e-IFU
www.ifu.straumann.com
Manufacturer
Date of manufacture
CE marking is the
manufacturer's
declaration that the
product meets the
requirements of the
applicable EC legislation
Symbol
Catalogue number
Batch code
SN
Serial number
Do not re-use
Non-sterile
Sterile
Sterilized using Ethylene
Oxide
Sterilized using aseptic
processing techniques
Sterilized using
irradiation
Sterilized using steam or
dry heat
Do not resterilize
Do not use if package is
damaged
Keep away from sunlight ISO 15223-1
U.S. federal law restricts
this device to sale by or
on the order of a dental
professional.
Qty
Quantity symbol
Use-by date
8˚C
Temperature limitation
46 F
(2 °C – 8 °C/36 °F – 46 °F)
2 ˚C
36 F
Keep dry
Caution
Symbol Source
ISO 15223-1
ISO 15223-1
ISO 15223-1
CE Certification
Mark
Symbol Description
Symbol Source
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
21 CFR 801.109(b)
(1)
Institut
Straumann AG
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
4