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

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

More countries (7)

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

More classes (11)

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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1,000+ devices foundsorted by relevance

Manufacturer: Biotec S.R.L.× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

Status

Regime

Registry

Class

Cutter stop, cutter stop ring, 3D assembly devices spacer UDI-DI +D748518NA61503

Biotec S.R.L.,Italy

Active Regimes: CE MDR Registry: EUDAMED Class:I
115 variants
Healing Abutment UDI-DI +D748201KS5A10B

Biotec S.R.L.,Italy

Active Regimes: CE MDR Registry: EUDAMED Class:IIb
173 variants
- Healing Abutment 201KR1A2
- Healing Abutment 330BU0A1.04
- Healing Abutment 330NA0A2.04
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Abutment UDI-DI +D748219KR3A20I

Biotec S.R.L.,Italy

Active Regimes: CE MDR Registry: EUDAMED Class:IIb
448 variants
- Abutment 210KS1A0
- Abutment 220EZ4D0
- Abutment 220KT3A1
- Abutment 261EN2A0
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CAD-CAM Base UDI-DI +D748247IS1A00E

Biotec S.R.L.,Italy

Active Regimes: CE MDR Registry: EUDAMED Class:IIb
316 variants
- CAD-CAM Base 246EA1A1
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Surgical instruments UDI-DI +D748445HR80009

Biotec S.R.L.,Italy

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
496 variants
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Impression Post UDI-DI +D748323KR0R00Q

Biotec S.R.L.,Italy

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
113 variants
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Overcasting Abutments UDI-DI +D748240BT1R00I

Biotec S.R.L.,Italy

Active Regimes: CE MDR Registry: EUDAMED Class:IIb
50 variants
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Scan Abutment UDI-DI +D748352BT1A207

Biotec S.R.L.,Italy

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
61 variants
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