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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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CAD-CAM Base UDI-DI +D748246KC1A100

Biotec S.R.L.,Italy Class IIb

Active CE MDR EUDAMED IIb
316 variants
- CAD-CAM Base 247IA1A0
- CAD-CAM Base 247QB1A0
- CAD-CAM Base 248KT1A1
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Healing Abutment UDI-DI +D748201KR2A309

Biotec S.R.L.,Italy Class IIb

Active CE MDR EUDAMED IIb
173 variants
- Healing Abutment 201SR2A0
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Surgical instruments UDI-DI +D748444HR3700A

Biotec S.R.L.,Italy Class IIa

Active CE MDR EUDAMED IIa
496 variants
- Surgical instruments 419HR202
- Surgical instruments 419HR426
- Surgical instruments 446HR500
- Surgical instruments 451HR312
- Surgical instruments 481HR370
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Abutment UDI-DI +D748MMO40N020+

Biotec S.R.L.,Italy Class IIb

Active CE MDR EUDAMED IIb
448 variants
- Abutment 220KR2E3
- Abutment 260ER6A0
- Abutment 261IR0A0
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Impression Post UDI-DI +D748325IW0A10F

Biotec S.R.L.,Italy Class IIa

Active CE MDR EUDAMED IIa
113 variants
- Impression Post 323BS0A0
- Impression Post 325KW0A0
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Scan Abutment UDI-DI +D748352EN1A002

Biotec S.R.L.,Italy Class IIa

Active CE MDR EUDAMED IIa
61 variants
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