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CERAMIR - Dental Products from Doxa
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Symbols glossary

Symbols glossary (updated in accordance with ISO 15223-1:2021)
SYMBOL
TITLE
​Designation number
Explanatory text
​Standard 
Picture
Manufacturer
5.1.1.
Indicates the medical device manufacturer, as defined in ISO 15223:2021.
* ​Yes

Picture
Date of manufacture
5.1.3.
Indicates the date when the medical device was manufactured
​* ​Yes

Picture
Use-by date
5.1.4.
Indicates the date after which the medical device is not to be used.
​* ​Yes

Picture
Batch code
5.1.5.
Indicates the manufacturer’s batch code so that the batch or lot can be identified. 
* ​Yes

Picture
Catalogue number
5.1.6.
Indicates the manufacturer’s catalogue number so that the medical device can be identified.
* ​Yes

Picture
Temperature limit
5.3.7.
Indicates the temperature limits to which the medical device can be safely exposed.
* ​Yes

Picture
Do not re-use
5.4.2.
Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
* ​Yes

Picture
Consult instructions for use
5.4.3.
Indicates the need for the user to consult the instructions for use.
* ​Yes

Picture
Caution
5.4.4.
Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that current situation needs operator awareness or operator action in order to avoid undesirable consequences.
This symbol shall not be used to solely mean “consult instructions for use”.
* ​Yes

Picture
Medical Device
5.5.7
Indicates the item is a medical device
* ​Yes

Picture
Prescription Use Only
21CFR 801.109
Caution: Federal (USA) law restricts this device to sale by or on the order of a dentist.
No

Picture
Radiopaque
-
The material is radiopaque.
No

Picture
Liquid
-
Bottle with Ceramir Crown & Bridge QuikMix Liquid
No

Picture
Powder
-
Jar with Ceramir Crown & Bridge QuikMix Powder
No

Picture
Scoop
-
Scoop to be used when dosing Ceramir Crown & Bridge QuikMix powder.
No

Picture
Mixing pad
-
Mixing pad delivered together with Ceramir Crown & Bridge QuikMix that can be used for mixing the cement.
No

Picture
Capsule
-
Indicates, together with a figure, the number of capsules in the package
No

Picture
No Pre-treatment
-
Do not use any pre-treatment agents, e.g. silanes, primers or bonding agents when cementing with Ceramir Crown & Bridge or Ceramir Bioceramic Implant Cement. Use of any such pre-treatments may compromise the bonding of the cement.
No

* ISO 15223-1:2021, not yet recognized by FDA.
Recognition Number 5-117: ISO 15223-1 Third Edition 2016-11-01, Medical devices - symbols to be used with medical device labels, labelling, and information to be supplied - part 1: General requirements.



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Ceramir® is a trademark of Doxa Dental AB

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