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ORAMETRIX, INC.

United States·US-MF-000018045

Last updated May 27, 2026

What ORAMETRIX, INC. makes

Orametrix produces orthodontic archwires, progressive aligners, and retainers designed for dental alignment treatment. Their portfolio also includes CAD/CAM software for digital treatment planning and appliance positioning trays to assist in orthodontic procedures. Examples include aligner systems like Motto and software solutions such as SureSmile Ortho Software, which integrates with digital scanning and treatment design workflows.

The company’s devices are regulated under FDA classifications, including Class I and Class II, with authorisations granted through 510(k) clearances and the FDA’s Unique Device Identification (UDI) system. Products are listed in the FDA’s regulatory databases, ensuring compliance with US medical device requirements. The company operates from the United States.

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

Information

Country: United States
Address: 1125 E Campbell Rd, Richardson, Texas, United States
Website: dentsplysirona.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(844)848-0137
PRRC Contact: Khyati Dave
EUDAMED SRN: US-MF-000018045
FDA FEI Number: —
DUNS Number: 053101262

Catalogue (29)

Device	Model / Reference	Registries	Class	Status
SureSmile®	ASSY-000110	FDA UDI	Class I	Active
Motto	ASSY-500017	FDA UDI	Class II	Active
SureSmile Advanced Software	7.6	EUDAMEDFDA UDI	Class I	Active
SureSmile®	ASSY-000580	FDA UDI	Class I	Active
SureSmile®	ASSY-000471	FDA UDI	Class I	Active
SureSmile®	DIGI-500128	FDA UDI	Class I	Active
SureSmile Ortho Software	7.6	EUDAMEDFDA UDI	Class I	Active
Motto	ASSY-500019	FDA UDI	Class I	Active
SureSmile®	ASSY-000472	FDA UDI	Class I	Active
Motto	ASSY-500118	FDA UDI	Class II	Active
SureSmile®	ASSY-000116	FDA UDI	Class I	Active
SureSmile attachment template	3000	FDA UDI	Class II	Active
SureSmile®	ASSY-000469	FDA UDI	Class I	Active
SureSmile®	ASSY-000112	FDA UDI	Class I	Active
sureclear template	2000	FDA UDI	Class II	Unknown
SureSmile®	ASSY-000117	FDA UDI	Class I	Active
SureSmile Aligner Software	7.6	EUDAMEDFDA UDI	Class I	Active
SureSmile®	1000	FDA UDI	Class II	Active
SureSmile®	ASSY-000108	FDA UDI	Class I	Active
SureSmile®	ASSY-000470	FDA UDI	Class I	Active
sureclear aligner	1000	FDA UDI	Class II	Unknown
SureSmile®	1000	FDA UDI	Class II	Active
SureSmile®	ASSY-000115	FDA UDI	Class I	Active
SureSmile®	ASSY-000473	FDA UDI	Class I	Active
SureSmile®	ASSY-000109	FDA UDI	Class I	Active
SureSmile®	1000	FDA UDI	Class I	Active
SureSmile®	ASSY-000149	FDA UDI	Class I	Active
SureSmile attachment template	2000	FDA UDI	Class II	Unknown
Suresmile System	K002620	FDA 510(k)	Class I	Active

Related Companies

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Authorities

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FDA Establishments (1)

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

OraMetrix GmbH Berlin Brandenburg · DE FEI 3003136642