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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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Implant replica UDI-DI +D748305BT0A002

Biotec S.R.L.,Italy Class I

Active CE MDR EUDAMED I
60 variants
- Implant replica AIO36I00
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CAD-CAM Base UDI-DI +D748247ER1A10A

Biotec S.R.L.,Italy Class IIb

Active CE MDR EUDAMED IIb
316 variants
- CAD-CAM Base 236IR0A1
- CAD-CAM Base 246ER3A1
- CAD-CAM Base 247CA1A0
- CAD-CAM Base 247CB1A1
- CAD-CAM Base 247EA1A1
- CAD-CAM Base 247TR1A1
- CAD-CAM Base 248IR1A0
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Abutment UDI-DI +D748266KS3G00P

Biotec S.R.L.,Italy Class IIb

Active CE MDR EUDAMED IIb
448 variants
- Abutment 220IM3A0
- Abutment 262IR5A0
- Abutment MMO60F00
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Scan Abutment UDI-DI +D748352IM1A005

Biotec S.R.L.,Italy Class IIa

Active CE MDR EUDAMED IIa
61 variants
- See all variants of this device
Retentive Screw UDI-DI +D748690NA0130$

Biotec S.R.L.,Italy Class IIb

Active CE MDR EUDAMED IIb
70 variants
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Surgical instruments UDI-DI +D748439HS5700H

Biotec S.R.L.,Italy Class IIa

Active CE MDR EUDAMED IIa
496 variants
- Surgical instruments 419HR341
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Reducer UDI-DI +D748502MA0140V

Biotec S.R.L.,Italy Class I

Active CE MDR EUDAMED I
9 variants
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Impression Post UDI-DI +D748323IM0A002

Biotec S.R.L.,Italy Class IIa

Active CE MDR EUDAMED IIa
113 variants
- See all variants of this device

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