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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 9 of 70

Device	Model / Reference	Registries	Class	Status
Resolve Ceramic	FRL322RHK	FDA UDI	Class II	Unknown
In-Ovation® R	189-451-80	FDA UDI	Class I	Unknown
Essiz A+	13125	FDA UDI	Class II	Active
Lowland	03-012-53T	FDA UDI	Class I	Unknown
Nubryte	03-016-58	FDA UDI	Class I	Unknown
Resolve Ceramic	FRU18BIHK	FDA UDI	Class II	Unknown
In-Ovation® R	189-341-10	FDA UDI	Class I	Unknown
In-Ovation® C	K100-152-81	FDA UDI	Class II	Unknown
Omniarch®	77-612-06	FDA UDI	Class I	Unknown
Omniarch®	77-231-73	FDA UDI	Class I	Unknown
Omniarch®	77-132-91	FDA UDI	Class I	Unknown
Ovation® C	310-612-00	FDA UDI	Class II	Unknown
Resolve® Ceramic	210-232-61	FDA UDI	Class II	Unknown
Ovation® C EURO	310-222-80	FDA UDI	Class II	Unknown
Ovation S	410-211-80	FDA UDI	Class I	Unknown
Omniarch®	77-441-13	FDA UDI	Class I	Unknown
Bioforce®	02-629-042	FDA UDI	Class I	Unknown
Essix C+®	1C500-BL	FDA UDI	Class II	Active
Mini Ovation®	85-121-00	FDA UDI	Class I	Unknown
Ovation®	82-232-00	FDA UDI	Class I	Unknown
Microarch®	72-232-11	FDA UDI	Class I	Unknown
Resolve® Ceramic	210-222-00	FDA UDI	Class II	Unknown
Generus® Ii	31-432-81	FDA UDI	Class I	Unknown
Microarch®	72-221-11	FDA UDI	Class I	Unknown
Microarch®	72-451-00	FDA UDI	Class I	Unknown
In-Ovation ® Mini	191-231-82	FDA UDI	Class I	Unknown
Picasso	PL001-PFW-RT	FDA UDI	Class II	Unknown
Microarch®+	J72-212-00	FDA UDI	Class I	Unknown
Ovation®	82-451-12	FDA UDI	Class I	Unknown
Ovation® C	310-611-00	FDA UDI	Class II	Unknown
Omniarch®	77-342-61	FDA UDI	Class I	Unknown
In-Ovation® C	100-612-08	FDA UDI	Class II	Unknown
Mini Ovation®	85-211-00	FDA UDI	Class I	Unknown
Square duraforce	DFS030X10SS	FDA UDI	U	Unknown
In-Ovation® C	100-212-08	FDA UDI	Class II	Unknown
In-Ovation® C	H100-242-10	FDA UDI	Class II	Unknown
Microarch®+	J72-121-11	FDA UDI	Class I	Unknown
Bioforce®	02-628-053	FDA UDI	Class I	Unknown
Omniarch®+	J77-352-60	FDA UDI	Class I	Unknown
In-Ovation® C	H100-122-08	FDA UDI	Class II	Unknown
Omniarch®	K77-055-30	FDA UDI	Class I	Unknown
Square duraforce	DFS040X100SS	FDA UDI	U	Unknown
In-Ovation® R	189-221-60	FDA UDI	Class I	Unknown
Ovation S	K410-151-10	FDA UDI	Class I	Unknown
In-Ovation® R	189-231-81	FDA UDI	Class I	Unknown
In-Ovation® C	H100-112-60	FDA UDI	Class II	Unknown
Microarch®	72-121-50	FDA UDI	Class I	Unknown
Round duraforce	DFSTG040X50R	FDA UDI	U	Unknown
Resolve Ceramic	CRL318RHK	FDA UDI	Class I	Unknown
Microarch®+	J72-112-60	FDA UDI	Class I	Unknown

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