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SYMBOL
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TITLE
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Designation number
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Explanatory text
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Standard
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Manufacturer
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5.1.1.
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Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
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* Yes
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Use-by date
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5.1.4.
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Indicates the date after which the medical device is not to be used.
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* Yes
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Batch code
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5.1.5.
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Indicates the manufacturer’s batch code so that the batch or lot can be identified.
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* Yes
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Catalogue number
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5.1.6.
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Indicates the manufacturer’s catalogue number so that the medical device can be identified.
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* Yes
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Temperature limit
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5.3.7.
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Indicates the temperature limits to which the medical device can be safely exposed.
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* Yes
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Do not re-use
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5.4.2.
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Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
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* Yes
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Consult instructions for use
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5.4.3.
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Indicates the need for the user to consult the instructions for use.
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* Yes
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Caution
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5.4.4.
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Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.
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* Yes
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Prescription Use Only
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21CFR 801.109
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Caution: Federal (USA) law restricts this device to sale by or on the order of a dentist.
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No
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Radiopaque
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-
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The cement is radiopaque.
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No
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Liquid
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-
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Bottle with Ceramir Crown & Bridge QuikMix Liquid
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No
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Powder
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-
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Jar with Ceramir Crown & Bridge QuikMix Liquid
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No
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Scoop
|
-
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Scoop to be used when dosing Ceramir Crown & Bridge QuikMix powder.
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No
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Mixing pad
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-
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Mixing pad delivered together with Ceramir Crown & Bridge QuikMix that can be used for mixing the cement.
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No
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Capsule
|
-
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Indicates, together with a figure, the number of capsules in the package
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No
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No Pre-treatment
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-
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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.
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No
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* 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.
US FR Recognition Number 5-117.
US FR Recognition Number 5-117.
