Results for “Dental Root Canal Rotary File”

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Registry EUDAMED 89 FDA 510(k) incl. De Novo FDA PMA GUDID 1

Country / market European Union (all) 89 United States 1

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Austria 67 France 19 Belgium 2 Germany 1

Risk class Class I 9 Class IIa 80 Class IIb Class III Class II (US)

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Class A Class B Class C Class D IVD General IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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Endo Rotary file

Denjoy Dental Co., Ltd,China

Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I
Root Canal Files

Shanghai Fanta Dental Materials Co., Ltd,China Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIa

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Results for “Dental Root Canal Rotary File”

Category (EMDN)

Endo Rotary file

Root Canal Files