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Registry EUDAMED ~1,466 FDA 510(k) ~2 FDA PMA GUDID ~1,109

Country / market European Union (all) ~1,426 United States ~1,109

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Spain ~733 Italy ~548 Portugal ~62 Germany ~59 Austria ~18 Hungary ~6

Risk class Class I ~136 Class IIa ~13 Class IIb ~1,399 Class III ~1 Class II (US) ~450

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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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Abutments for Dental Implants UDI-DI 08033707098799

Leone S.P.A.,Italy Class IIb

Active CE MDD EUDAMEDGUDID IIb
199 variants
- Abutments for Dental Implants 120-4110-30
- Abutments for Dental Implants 121-3306-15
- Abutments for Dental Implants 123-3300-05
- Abutments for Dental Implants 124-4103-04
- Abutments for Dental Implants 126-2205-07
- Abutments for Dental Implants 126-3005-01
- Abutments for Dental Implants 126-4117-01
- Abutments for Dental Implants 126-4801-01
- Abutments for Dental Implants 127-4801-10
- Abutments for Dental Implants 129-3303-02
- Abutments for Dental Implants 129-4102-02
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Dental implants UDI-DI 08033707071884

Leone S.P.A.,Italy Class IIb

Active CE MDD EUDAMEDGUDID IIb
137 variants
- Dental implants 110-3814-02
- Dental implants 126-2221-07
- Dental implants 126-3021-01
- Dental implants 126-3025-01
- Dental implants 126-3321-15
- Dental implants 131-3305-45
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Dental Implants - Externa Universal/ Universal Plus UDI-DI 08435389815204

B.T.I. Biotechnology Institute, S.l,Spain Class IIb

Active CE MDR EUDAMEDGUDID IIb
24 variants
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