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Dentsply Implants Manufacturing GmbH

Last updated May 24, 2026

What Dentsply Implants Manufacturing GmbH makes

The company produces dental implant components, including temporary and permanent preformed suprastructures for single-use or reusable applications, as well as two-piece screw endosteal implants. It also manufactures transgingival implants, reusable dental drill bits, surgical screwdrivers, and fluted surgical drill bits designed for dental procedures. These products are used in implantology for fixture placement and restoration.

The portfolio includes devices classified as Class I, Class II, and unclassified (U) under regulatory frameworks, with listings in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable domestic and international medical device regulations.

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

Information

Country: US
Address: —
Website: dentsplysirona.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)531-3481
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 344038836

Catalogue (4186)

Page 7 of 84

Device	Model / Reference	Registries	Class	Status
ASTRA TECH Implant System®	24975	FDA UDI	Class II	Active
Astra Tech Implant System®	25397	FDA UDI	Class I	Active
ASTRA TECH Implant System® EV	25700	FDA UDI	Class II	Active
Astra Tech Implant System®	25485	FDA UDI	Class I	Active
Friadent®	32469550	FDA UDI	Class II	Active
Friadent®	32462255	FDA UDI	Class II	Unknown
Friadent®	32454240	FDA UDI	Class II	Active
Friadent®	45-5650	FDA UDI	Class I	Active
Friadent®	32451443	FDA UDI	Class II	Active
Astra Tech Implant System®	22960	FDA UDI	Class I	Active
Ankylos®	31023430	FDA UDI	Class II	Active
Friadent®	32462225	FDA UDI	Class II	Unknown
Ankylos®	31023015	FDA UDI	Class II	Unknown
Astra Tech Implant System®	26234	FDA UDI	Class I	Active
XiVE®	26-1603	FDA UDI	Class I	Active
DS Implants	68012203	FDA UDI	Class II	Unknown
DS Implants	68012234	FDA UDI	Class I	Active
Friadent®	32453241	FDA UDI	Class II	Active
Ankylos®	31024183	FDA UDI	Class II	Active
DS Implants	68012243	FDA UDI	Class II	Active
DS Implants	68014009	FDA UDI	Class I	Active
DS OmniTaper	68017110	FDA UDI	Class I	Active
Astra Tech Implant System®	26017	FDA UDI	Class I	Active
Ankylos®	31021648	FDA UDI	Class II	Unknown
XiVE®	32252445	FDA UDI	Class II	Unknown
DS PrimeTaper	68017301	FDA UDI	Class I	Active
Friadent®	32468145	FDA UDI	Class II	Unknown
Astra Tech Implant System®	22069	FDA UDI	Class I	Active
ASTRA TECH Implant System®	24189	FDA UDI	Class II	Active
DS PrimeTaper	68011085	FDA UDI	Class II	Active
DS Implants	68013026	FDA UDI	Class II	Active
Friadent®	32453151	FDA UDI	Class II	Active
DS Implants	68012233	FDA UDI	Class II	Unknown
Friadent®	32454840	FDA UDI	Class II	Active
DS OmniTaper	68015092	FDA UDI	Class I	Active
Astra Tech Implant System®	25988	FDA UDI	Class I	Active
ASTRA TECH Implant System®	24154	FDA UDI	Class II	Active
XiVE®	32264105	FDA UDI	Class II	Active
XiVE®	26-1152	FDA UDI	Class I	Active
ASTRA TECH Implant System®	24245	FDA UDI	Class II	Active
Friadent®	45-5035	FDA UDI	Class I	Active
ASTRA TECH Implant System® EV	25280	FDA UDI	Class II	Active
DS Implants	68012233	FDA UDI	Class II	Active
XiVE®	26-5511	FDA UDI	Class I	Active
XiVE®	32264005	FDA UDI	Class II	Active
Ankylos®	31021150	FDA UDI	Class II	Active
XiVE®	32463042	FDA UDI	Class II	Active
DS Implants	68012017	FDA UDI	Class II	Active
DS OmniTaper	68017014	FDA UDI	Class I	Active
DS Implants	68012047	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Dentsply Implants Manufacturing GmbH Hanau Hesse · DE FEI 3013111692