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4
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SYMBOL
TITLE
EXPLANATORY TEXT
STANDARD
REFERENCE
Non-Sterile
Indicates a medical device that has not been
subjected to a sterilization process
EN ISO 15223-1
5.2.7
Date of Manufacture
Indicates the date when the medical
device was manufactured.
EN ISO 15223-
1
5.1.3
European Mark of
Conformity
Indicates device is in conformance with
Medical Device Regulation EU 2017/745
MDR EU
2017/745
Annex V
Rx only
Federal law restricts this device to sale
by or on the order of a dentist only
US CFR
Title 21
801.15(c)(1)
(i)(F)
Quantity
Indicates the number of items within the
package
N/A
N/A
Unique Device
Identifier
Indicates as containing Unique Device
Identifier information
ISO 15223-1
5.7.10
Medical device
Indicates the item is a medical device
ISO 15223-1
5.7.7
Do not re-use
Indicates a medical device that is
intended for one single use only
ISO 15223-1
5.4.2
Distributor
Indicates the entity distributing the
medical device in the locale
ISO 15223-1
5.1.9
Zest Anchors, LLC
JOTA AG Rotary Instruments
2875 Loker Avenue East
Hirschensprungstrasse 2
Carlsbad, CA 92010 USA
9464 Rüthi, Switzerland
www.zestdent.com
Made in Switzerland
+41 (0) 71 767 79 99
L8114-ZD Rev D 2021-09
CHAIRSIDE and ZEST are registered trademarks and Zest
Dental Solutions is a trademark of ZEST IP Holdings, LLC
U.S. Patents: Refer to www.zestdent.com/patents
