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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 5 of 84

Device	Model / Reference	Registries	Class	Status
XiVE®	26-1640	FDA UDI	Class I	Active
Friadent®	32461220	FDA UDI	Class II	Unknown
Friadent®	32453201	FDA UDI	Class II	Unknown
XiVE®	32463100	FDA UDI	Class II	Unknown
DS PrimeTaper	68011100	FDA UDI	Class II	Active
Friadent®	45-4560	FDA UDI	Class I	Active
Astra Tech Implant System®	26049	FDA UDI	Class I	Active
DS PrimeTaper	68011089	FDA UDI	Class II	Active
XiVE®	32262431	FDA UDI	Class II	Active
ASTRA TECH Implant System®	25057	FDA UDI	Class II	Active
Friadent®	45-1655	FDA UDI	Class I	Active
DS OmniTaper	68012002	FDA UDI	Class II	Active
ASTRA TECH Implant System®	24001	FDA UDI	Class II	Active
DS Implants	68013070	FDA UDI	Class II	Active
DS Implants	68014010	FDA UDI	Class I	Active
Simplant®	68017217	FDA UDI	Class I	Active
Friadent®	32468150	FDA UDI	Class II	Unknown
ASTRA TECH Implant System® EV	26165	FDA UDI	Class II	Active
DS Implants	68012049	FDA UDI	Class II	Unknown
Astra Tech Implant System®	25989	FDA UDI	Class I	Active
DS Implants	68012166	FDA UDI	Class II	Unknown
XiVE®	26-5395	FDA UDI	Class I	Active
ASTRA TECH Implant System® EV	25797	FDA UDI	Class II	Active
XiVE®	26-2155	FDA UDI	Class I	Active
Ankylos®	31024014	FDA UDI	Class II	Unknown
ASTRA TECH Implant System®	24121	FDA UDI	Class II	Active
Friadent®	46-7001	FDA UDI	Class I	Active
Astra Tech Implant System®	22885	FDA UDI	Class I	Active
Ankylos®	31045802	FDA UDI	Class I	Active
XiVE® TG	25-5020	FDA UDI	Class I	Active
Astra Tech Implant System®	22803	FDA UDI	Class I	Active
XiVE®	32261933	FDA UDI	Class II	Active
DS PrimeTaper	68011106	FDA UDI	Class II	Active
Astra Tech Implant System®	26060	FDA UDI	Class I	Active
DS Implants	68013030	FDA UDI	Class II	Active
Ankylos®	31024111	FDA UDI	Class II	Active
ASTRA TECH Implant System® EV	25756	FDA UDI	Class II	Active
Astra Tech Implant System®	24097	FDA UDI	Class I	Active
Ankylos®	31010410	FDA UDI	Class II	Unknown
Ankylos®	31034382	FDA UDI	Class I	Active
ASTRA TECH Implant System®	24064	FDA UDI	Class II	Unknown
Friadent®	32464300	FDA UDI	Class II	Unknown
DS OmniTaper	68017116	FDA UDI	Class I	Active
Simplant®	31830729	FDA UDI	Class I	Active
ASTRA TECH Implant System®	24580	FDA UDI	Class II	Active
Ankylos®	31024181	FDA UDI	Class II	Unknown
DS Implants	68013011	FDA UDI	Class II	Unknown
Astra Tech Implant System®	26053	FDA UDI	Class I	Active
Ankylos®	31023470	FDA UDI	Class II	Active
Ankylos®	31010453	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