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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

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Abutment UDI-DI +D748211KR3A008

Biotec S.R.L.,Italy

Active Regimes: CE MDR Registry: EUDAMED Class:IIb
448 variants
- Abutment 210IR2A0
- Abutment 261IR4A0
- Abutment 261KS6A0
- Abutment 262KS1A0
- Abutment 265KR2R0
- Abutment 266IR3J1
- Abutment MMP40N12
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Healing Abutment UDI-DI +D748201VR7A00M

Biotec S.R.L.,Italy

Active Regimes: CE MDR Registry: EUDAMED Class:IIb
173 variants
- Healing Abutment 201KR5A3
- See all variants of this device
Surgical instruments UDI-DI +D748476HR3300B

Biotec S.R.L.,Italy

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
496 variants
- Surgical instruments 419HR313
- Surgical instruments 419HR423
- Surgical instruments 435HS430
- Surgical instruments 451HR316
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CAD-CAM Base UDI-DI +D748246KU1A10I

Biotec S.R.L.,Italy

Active Regimes: CE MDR Registry: EUDAMED Class:IIb
316 variants
- CAD-CAM Base 246IG1A0
- CAD-CAM Base 249IR1A1
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Implant replica UDI-DI +D748305SR0A00H

Biotec S.R.L.,Italy

Active Regimes: CE MDR Registry: EUDAMED Class:I
60 variants
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Retentive Screw UDI-DI +D748690NA24907

Biotec S.R.L.,Italy

Active Regimes: CE MDR Registry: EUDAMED Class:IIb
70 variants
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