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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 3 of 84

Device	Model / Reference	Registries	Class	Status
Friadent®	32462242	FDA UDI	Class II	Active
XiVE®	26-2053	FDA UDI	Class I	Active
Friadent®	32452530	FDA UDI	Class II	Unknown
DS Implants	68014019	FDA UDI	Class I	Active
XiVE®	26-2063	FDA UDI	Class I	Active
Astra Tech Implant System® EV	26414	FDA UDI	Class II	Active
Friadent®	45-5661	FDA UDI	Class I	Active
Astra Tech Implant System®	26232	FDA UDI	Class I	Active
DS Implants	68013002	FDA UDI	Class II	Unknown
Ankylos®	31010470	FDA UDI	Class II	Unknown
Friadent®	45-1639	FDA UDI	Class I	Active
XiVE®	26-1231	FDA UDI	Class I	Active
ASTRA TECH Implant System®	24006	FDA UDI	Class II	Unknown
Ankylos®	31021310	FDA UDI	Class II	Active
XiVE®	26-1630	FDA UDI	Class I	Active
Ankylos®	31021070	FDA UDI	Class II	Active
DS Implants	68017003	FDA UDI	Class I	Active
Symbios®	32597401	FDA UDI	Class II	Unknown
DS PrimeTaper	68011115	FDA UDI	Class II	Unknown
ASTRA TECH Implant System®	24892	FDA UDI	Class II	Active
Ankylos®	31021528	FDA UDI	Class II	Unknown
DS Implants	68013032	FDA UDI	Class II	Active
DS OmniTaper	68017016	FDA UDI	Class I	Active
DS OmniTaper	68015088	FDA UDI	Class I	Active
Ankylos®	31023311	FDA UDI	Class II	Active
Xive®	32261941	FDA UDI	Class II	Unknown
Astra Tech Implant System®	25855	FDA UDI	Class I	Active
Friadent®	32462163	FDA UDI	Class II	Unknown
Friadent®	32451650	FDA UDI	Class II	Unknown
ASTRA TECH Implant System® EV	26196	FDA UDI	Class II	Active
Friadent®	32452560	FDA UDI	Class II	Unknown
ASTRA TECH Implant System®	25054	FDA UDI	Class II	Active
Friadent®	32452440	FDA UDI	Class II	Unknown
Ankylos®	31023310	FDA UDI	Class II	Unknown
Astra Tech Implant System® EV	26372	FDA UDI	Class II	Active
Astra Tech Implant System®	25420	FDA UDI	Class I	Active
Ankylos®	31010140	FDA UDI	Class II	Unknown
Astra Tech Implant System®	25408	FDA UDI	Class I	Active
ASTRA TECH Implant System®	25042	FDA UDI	Class II	Unknown
Astra Tech Implant System®	25790	FDA UDI	Class I	Active
ASTRA TECH Implant System® EV	25366	FDA UDI	Class II	Active
Astra Tech Implant System®	22910	FDA UDI	Class I	Active
XiVE®	32463032	FDA UDI	Class II	Active
Ankylos®	31056024	FDA UDI	Class II	Unknown
Friadent®	46-1650	FDA UDI	Class I	Active
Simplant®	31830737	FDA UDI	Class I	Active
Astra Tech Implant System®	22887	FDA UDI	Class I	Active
ASTRA TECH Implant System® EV	25284	FDA UDI	Class II	Active
ASTRA TECH Implant System®	25044	FDA UDI	Class II	Active
DS Implants	68013025	FDA UDI	Class II	Active

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