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Alpha Bio Tec Ltd.

Israel·IL-MF-000021145

Last updated September 18, 2026

What Alpha Bio Tec Ltd. makes

Alpha Bio Tec Ltd. manufactures dental implants and related components, including customizable and standard abutments, healing abutments, and titanium bases for restorative procedures. Their portfolio includes short and narrow implant bodies, customizable molar abutments, and CAD/CAM titanium bases designed for specific anatomical applications. Temporary abutments and spiral implants are also part of their offerings, catering to both immediate and delayed loading protocols in dental restoration.

The company’s devices are classified under EU medical device regulations as Class IIa and Class IIb, reflecting varying levels of risk and regulatory oversight. These products are registered in the EU’s eudamed database, ensuring compliance with European Union medical device directives. Alpha Bio Tec Ltd. is based in Israel.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Israel
Address: 21, 21 HaReches Blvd., POB 264, Modi'in, 7171102, Modi'in, Israel
Website: alpha-bio.net/il/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +972 504589683
PRRC Contact: Shani Aroch
EUDAMED SRN: IL-MF-000021145
FDA FEI Number: —
DUNS Number: —

Catalogue (859)

Page 14 of 18

Device	Model / Reference	Registries	Class	Status
Open Tray Transfer	5061	EUDAMED	Class I	Active
Surgical Drill D2.4mm – L16mm	65074	EUDAMED	Class IIa	Active
AlphaLoC Block Out Spacer	4883	EUDAMED	Class I	Active
Intraoral Scan Body CSL	3837	EUDAMED	Class I	Active
Alpha Bio Bone Fixation Screw System	K063769	FDA 510(k)	Class II	Active
Alpha-Bio Orthodontic Fixation Screw System	K063770	FDA 510(k)	Class II	Active
Alpha Bio Dental Implant System	K063364	FDA 510(k)	Class II	Active
Implant Mount Extractor	65045	EUDAMED	Class I	Active
TRZ Scan Body CHC	3839	EUDAMED	Class I	Active
Implant Mount CS Small	65064	EUDAMED	Class I	Active
AlphaLoC Male-Laboratory black units(X4)	4882	EUDAMED	Class I	Active
Closed Tray Transfer	5060	EUDAMED	Class I	Active
Analog for D3.5 MU	5644	EUDAMED	Class I	Active
Open tray transfer short AR CHC	3308	EUDAMED	Class I	Active
Open tray transfer for D3.5 MU R	5643	EUDAMED	Class I	Active
Casting sleeve for D4.8 MU R	5749	EUDAMED	Class I	Active
Manual TX driver vertical - Long	5479	EUDAMED	Class I	Active
Surgical Drill D4.5mm – L13mm	65035	EUDAMED	Class IIa	Active
Drill External Irrigation D3.65mm	4654	EUDAMED	Class IIa	Active
Drill External Irrigation D4.5mm	4676	EUDAMED	Class IIa	Active
Scan Body - Screw Retained TCT-N-R	3883	EUDAMED	Class I	Active
Implant Grip Driver Long 2.5mm	4140	EUDAMED	Class I	Active
Drill External Irrigation D3.2mm	4324	EUDAMED	Class IIa	Active
TRZ Scan Body IH	3834	EUDAMED	Class I	Active
Alpha Step Drill_4.5/4.8	4598	EUDAMED	Class IIa	Active
Drill External Irrigation D2.0mm	4204	EUDAMED	Class IIa	Active
Analog for D4.8 MU	5744	EUDAMED	Class I	Active
Implant Hand Driver 2.1mm CHC	4147	EUDAMED	Class I	Active
Motor Mount Driver Short 2.5mm CS	3804	EUDAMED	Class IIa	Active
Alpha Straight Drill_D2.8	4552	EUDAMED	Class IIa	Active
Surgical Drill D3.6mm – L13mm	65025	EUDAMED	Class IIa	Active
Short Closed Tray Transfer	5170	EUDAMED	Class I	Active
Advanced Surgical Organizer Box	4613	EUDAMED	Class I	Active
Slim Closed Tray Transfer	5062	EUDAMED	Class I	Active
Alpha Straight Drill_D4.8	4558	EUDAMED	Class IIa	Active
TRZ Scan body for D4.8 MU	5740	EUDAMED	Class I	Active
Retriever driver MUA	5700	EUDAMED	Class I	Active
Short Parallel Depth Guide	4081	EUDAMED	Class I	Active
AlphaLoC Female Analog (X4)	4885	EUDAMED	Class I	Active
Drilling Parallel Guide	4082	EUDAMED	Class I	Active
Drill External Irrigation D2.8mm	4284	EUDAMED	Class IIa	Active
Ratchet TX driver angled- Standard	5548	EUDAMED	Class I	Active
Mini Surgical Organizer Box – Step drills	4774	EUDAMED	Class I	Active
Securing Sleeve	66014	EUDAMED	Class I	Active
Crestal Pin Large	65049	EUDAMED	Class IIa	Active
Surgical Drill D3.2mm – L10mm	65018	EUDAMED	Class IIa	Active
Implant Mount Screw CHC	65056	EUDAMED	Class I	Active
Sirona CAD/CAM Scan Post	4984	EUDAMED	Class I	Active
Surgical Drill D4.1mm – L16mm	65031	EUDAMED	Class IIa	Active
Alpha Step Drill_2.8/3.2	4594	EUDAMED	Class IIa	Active

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