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Registry EUDAMED ~399 FDA 510(k) ~1 FDA PMA GUDID

Country / market European Union (all) ~387 United States ~1

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Italy ~332 Austria ~25 Netherlands ~20 Germany ~6 Türkiye ~4 Greece ~3 France ~1

Risk class Class I ~25 Class IIa ~15 Class IIb ~41 Class III Class II (US) ~1

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Class A ~189 Class B Class C ~3 Class D IVD General ~126 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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Manufacturer: Biotec S.R.L.× Clear all

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Cutter stop, cutter stop ring, 3D assembly devices spacer UDI-DI +D748518NA2000-

Biotec S.R.L.,Italy Class I

Active CE MDR EUDAMED I
115 variants
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Implant replica UDI-DI +D748301NA0A10Z

Biotec S.R.L.,Italy Class I

Active CE MDR EUDAMED I
60 variants
- Implant replica 305LR0A0
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CAD-CAM Base UDI-DI +D748247KT1A20J

Biotec S.R.L.,Italy Class IIb

Active CE MDR EUDAMED IIb
316 variants
- CAD-CAM Base 246ER1A1
- CAD-CAM Base 247BT1A2
- CAD-CAM Base 247IG1A0
- CAD-CAM Base 247IR1A0
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Surgical instruments UDI-DI +D748426HR3850G

Biotec S.R.L.,Italy Class IIa

Active CE MDR EUDAMED IIa
496 variants
- Surgical instruments 424HR250
- Surgical instruments 440HS420
- Surgical instruments 466HR330
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Abutment UDI-DI +D748220IW2D00D

Biotec S.R.L.,Italy Class IIb

Active CE MDR EUDAMED IIb
448 variants
- Abutment 262KS7A0
- Abutment 265KS1R0
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Dental Implants UDI-DI +D748140DR37Q0P

Biotec S.R.L.,Italy Class IIb

Active CE MDR EUDAMED IIb
447 variants
- Dental Implants 116IR40J
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Healing Abutment UDI-DI +D748201VR2A10I

Biotec S.R.L.,Italy Class IIb

Active CE MDR EUDAMED IIb
173 variants
- Healing Abutment 201EZ6A0
- Healing Abutment 201IR3A2
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