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Dentsply Sirona Orthodontics Inc.

United States·US-MF-000002029

Last updated September 17, 2026

Information

Country: United States
Address: 7290 26th Court East, Sarasota, Florida, United States
Website: dentsplysirona.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Scott Lurgio
EUDAMED SRN: US-MF-000002029
FDA FEI Number: 3001947560
DUNS Number: —

Catalogue (3454)

Page 5 of 70

Device	Model / Reference	Registries	Class	Status
In-Ovation® R	189-341-80	FDA UDI	Class I	Unknown
In-Ovation ® Mini	191-112-00	FDA UDI	Class I	Unknown
Ovation S	410-641-00	FDA UDI	Class I	Unknown
In-Ovation® R	189-441-60	FDA UDI	Class I	Unknown
Perio Bendable	TIP3006005	FDA UDI	Class II	Unknown
In-Ovation® L	190-611-00	FDA UDI	Class I	Unknown
Neo Sentalloy®	02-623-172	FDA UDI	Class I	Unknown
Microarch®	72-251-00	FDA UDI	Class I	Unknown
In-Ovation® C	H100-211-08	FDA UDI	Class II	Unknown
Microarch®	72-231-12	FDA UDI	Class I	Unknown
In-Ovation® R	189-332-00	FDA UDI	Class I	Unknown
Pentacat®	03-175-23	FDA UDI	Class I	Unknown
Duraforce	DFS060X50S	FDA UDI	U	Unknown
Essix A+	10065-25	FDA UDI	Class II	Active
In-Ovation® R	189-432-00	FDA UDI	Class I	Unknown
Ovation S	410-351-10	FDA UDI	Class I	Unknown
Omniarch®	77-212-72	FDA UDI	Class I	Unknown
In-Ovation® C	100-112-00	FDA UDI	Class II	Unknown
Omniarch®	76-452-10	FDA UDI	Class I	Unknown
In-Ovation® R	189-111-08	FDA UDI	Class I	Unknown
Microarch®	72-311-05	FDA UDI	Class I	Unknown
In-Ovation ® Mini	191-551-80	FDA UDI	Class I	Unknown
Omniarch®	77-122-90	FDA UDI	Class I	Unknown
Mystique® Mb	110-121-00	FDA UDI	Class II	Unknown
Omniarch®	77-352-13	FDA UDI	Class I	Unknown
Omniarch®	77-232-22	FDA UDI	Class I	Unknown
Omniarch®+	J77-611-00	FDA UDI	Class I	Unknown
Microarch®	72-641-51	FDA UDI	Class I	Unknown
In-Ovation ® Mini	191-351-80	FDA UDI	Class I	Unknown
Omniarch®	77-541-03	FDA UDI	Class I	Unknown
Omniarch®	77-611-06	FDA UDI	Class I	Unknown
Omniarch®	77-342-14	FDA UDI	Class I	Unknown
Bioforce®	02-628-523	FDA UDI	Class I	Unknown
Microarch®	72-331-61	FDA UDI	Class I	Unknown
Mystique® Mb	110-222-90	FDA UDI	Class II	Unknown
Omniarch®+	J77-142-10	FDA UDI	Class I	Unknown
Mini Ovation®	85-342-00	FDA UDI	Class I	Unknown
Microarch®	72-121-03	FDA UDI	Class I	Unknown
In-Ovation ® Mini	191-341-80	FDA UDI	Class I	Unknown
Essix ACE®	1AH50PLAS	FDA UDI	Class I	Unknown
Omniarch®	77-132-04	FDA UDI	Class I	Unknown
In-Ovation ® X	289-341-10	FDA UDI	Class I	Unknown
In-Ovation ® Mini	191-132-10R	FDA UDI	Class I	Unknown
Omniarch®	77-142-90	FDA UDI	Class I	Unknown
MTM® Clear Aligner	MTMALSA100	FDA UDI	Class II	Unknown
Posterior Lower Pontic	PUMO-G	FDA UDI	Class II	Active
Microarch®+	J72-341-00	FDA UDI	Class I	Unknown
Bi-Dimensional	03-000-03	FDA UDI	Class I	Unknown
In-Ovation ® Mini	191-552-80	FDA UDI	Class I	Unknown
In-Ovation® R	189-341-00	FDA UDI	Class I	Unknown

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