We are trying to submit a 510(k) for
a biphasic dental cement which has a 70/30 ratio of Hydroxyapatite / Tricalcium Phosphate. All predicates at the FDA database have a 60/40 ratio. Does anyone know if there is a limitation for that ratio? -------------------------------------------
Lilian Llull
Techlink International
Sunny Isles FL
United States
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