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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 11 of 70

Device	Model / Reference	Registries	Class	Status
Essix	12500	FDA UDI	U	Active
Microarch®+	J72-232-10	FDA UDI	Class I	Unknown
Ovation®	03-128-642	FDA UDI	Class I	Unknown
In-Ovation ® Mini	191-542-80	FDA UDI	Class I	Unknown
In-Ovation® R	189-341-60	FDA UDI	Class I	Unknown
In-Ovation® C	100-232-00	FDA UDI	Class II	Unknown
In-Ovation® R	189-352-10	FDA UDI	Class I	Unknown
Balance (tm)	31-432-15	FDA UDI	Class I	Unknown
In-Ovation ® X	289-441-10	FDA UDI	Class I	Unknown
Ovation®	82-111-00	FDA UDI	Class I	Unknown
In-Ovation® R	189-142-13	FDA UDI	Class I	Unknown
Omniarch®	77-642-03	FDA UDI	Class I	Unknown
In-Ovation® C	K100-152-80	FDA UDI	Class II	Unknown
In-Ovation ® X	289-412-00	FDA UDI	Class I	Unknown
Omniarch®	77-342-13	FDA UDI	Class I	Unknown
Omniarch®	77-331-60	FDA UDI	Class I	Unknown
Bioforce®	02-628-593	FDA UDI	Class I	Unknown
Omniarch®	77-131-73	FDA UDI	Class I	Unknown
Omniarch®	77-132-71	FDA UDI	Class I	Unknown
In-Ovation® R	189-331-10	FDA UDI	Class I	Unknown
Ovation S	410-651-80	FDA UDI	Class I	Unknown
Omniarch®	77-241-61	FDA UDI	Class I	Unknown
In-Ovation® C	100-541-80	FDA UDI	Class II	Unknown
Omniarch®	77-122-91	FDA UDI	Class I	Unknown
Resolve® Ceramic	K210-151-12	FDA UDI	Class II	Unknown
Omniarch®	77-431-03	FDA UDI	Class I	Unknown
Microarch®	72-252-10	FDA UDI	Class I	Unknown
In-Ovation ® X	289-142-90	FDA UDI	Class I	Unknown
In-Ovation® R	189-342-80	FDA UDI	Class I	Unknown
Duraguard	DGSB160X25S	FDA UDI	U	Unknown
Generus® Ii	31-442-81	FDA UDI	Class I	Unknown
In-Ovation® C	H100-121-80	FDA UDI	Class II	Unknown
Microarch®	72-332-02	FDA UDI	Class I	Unknown
Essix A+®	11040-50	FDA UDI	Class II	Unknown
Ovation® C EURO	310-121-80	FDA UDI	Class II	Unknown
Omniarch®+	J77-251-10	FDA UDI	Class I	Unknown
Mini Ovation®	85-132-00	FDA UDI	Class I	Unknown
Microarch®	72-121-11	FDA UDI	Class I	Unknown
Square duraclear	DCS030X2S	FDA UDI	U	Unknown
Microarch®	72-242-13	FDA UDI	Class I	Unknown
Ovation® C	310-432-00	FDA UDI	Class II	Unknown
Omniarch®	77-121-72	FDA UDI	Class I	Unknown
Duraguard	DGSC060X25R	FDA UDI	U	Unknown
Ovation®	82-222-01	FDA UDI	Class I	Unknown
In-Ovation® R	189-112-00	FDA UDI	Class I	Unknown
Omniarch®	77-121-40	FDA UDI	Class I	Unknown
Microarch®	72-251-61	FDA UDI	Class I	Unknown
Omniarch®	77-341-90	FDA UDI	Class I	Unknown
Thermoplier®	82550	FDA UDI	Class II	Unknown
Omniarch®+	J77-342-61	FDA UDI	Class I	Unknown

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