Results for “Orthodontic Metal Brackets”

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Registry EUDAMED 730 FDA 510(k) incl. De Novo 2 FDA PMA GUDID

Country / market European Union (all) 730 United States 2

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Austria 717 Germany 11 Spain 1 Poland 1

Risk class Class I Class IIa 730 Class IIb Class III Class II (US) 2

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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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Orthodontic Metal Brackets

Creative Dental,China Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
Orthodontic Metal Brackets

Zhejiang Protect Medical Equipment Co., Ltd.,China Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:IIa

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deviCERTS Global Medical Device Regulatory Database

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