MDR Information Teeth
Future requirements for the dental laboratory:
Documentation from goods received to processing must be guaranteed for each individual tooth.
In the course of this year, REF numbers and batches of individual sets of teeth will be listed on every delivery document regarding Merz Dental teeth, which enables the data to be entered into laboratory management software.
Our service for you:
For our customers who already work with documentation software, we offer an allocation chart in Excel format. This contains information on all Merz Dental tooth lines according to article name, mould, color and size as well as the corresponding REF number. Entering the data into a documentation software is quick and easy. You can download the chart from www.merz-dental.de.
Please note! However, plain documentation from the transfer of the data on the delivery note does not usually meet the new MDR requirements, since a tooth set and thus the batch are only assigned when the dental work is produced. Therefore, on the back of the tooth sets there is also a label with all the necessary information to ensure batch traceability. There is also a QR code on the front with all the necessary information. Depending on the type of documentation system, the information can be read out in different ways and transferred into the system.
Which standards does the DataMatrix code comply with?
• The quality of our barcodes is randomly checked using a special test device in accordance with the international standards ISO/IEC 15415, ISO/IEC 15416 and ISO/IEC TR 29158 (Vericube).
• The measuring accuracy of the device conforms to ISO/IEC 15426-2 and ISO/IEC 15426-1.
• The DataMatrix code already meets the requirements of the MDR-UDI, which will apply from 2023, in the area of standardized international labeling of medical devices.
• The applied codes are already checked at Merz Dental in a standardized procedure that corresponds to future guidelines.
Why is the code displayed on the tooth set so small and what are the advantages?
• We have placed the code on the front to allow scanning from within the tooth cabinet or from the delivery trays without removing the sets.
• The code includes the REF number, the batch and in the future also the expiry date.
• All information is available on the front of the tooth set, so that reordering or taking inventory of the tooth cabinet is quick and easy.
• In this way, it can be entered into your own documentation system without any problems.
• On the back is the content of the code again in plain text.