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Dear all,
Do you have experience with selection of EMDN codes (EU-MDR) for dental medical devices, such as abutments?
I am aware of the EU documents viewing dental implants and abutments such as class IIb.
So I would tend to assign to all abutments (including temporary healing abutment/caps, locator abutments), the same EMDN, namely: P01020101. This is identical to dental implants. All of them are very likely long-term (more than 30 days) implantable devices in the patient.
Glad to have some answers/feedback. Thank you!