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Life time of product for a biodegradable device

Discussion in 'Medical Devices (21 CFR Part 820)' started by Gözde Aktener, Aug 31, 2018.

  1. Gözde Aktener

    Gözde Aktener New Member

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    how can we define life time of product for a biodegradable device? I work on a technical file of a synthetic bone graft substitute. I have to define a life time of product for bone graft but I m a little bit confused about that;

    biodegredation duration of bone graft : 6-12 months
    resorption duration of bone graft: >9 (few clinical report)

    device completes its performance in 6-12 months*
     
  2. Frank93

    Frank93 New Member

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    The bone graft dental procedure takes between 45-90 minutes and is performed in your dentist's clinic. The initial recovery period lasts about two weeks. Following the bone graft procedure, the waiting time until a solid bone mass is received is between 3-6 months, in most clinical cases.
     
  3. Gözde Aktener

    Gözde Aktener New Member

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    Thank you for your response. The test is completed in 3 months, test medium was tris buffer which simulates human body conditions. The product has received CE apporaval in last year.
     

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