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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 3 of 70

Device	Model / Reference	Registries	Class	Status
Ovation S	410-441-10	FDA UDI	Class I	Unknown
In-Ovation® R	189-351-80	FDA UDI	Class I	Unknown
Omniarch®	76-152-10	FDA UDI	Class I	Unknown
Mini Ovation®	85-412-02	FDA UDI	Class I	Unknown
IN-OVATION® Czr	100-442-10	FDA UDI	Class II	Unknown
In-Ovation® R	189-551-80	FDA UDI	Class I	Unknown
Mtm®	82IKIT-C	FDA UDI	Class II	Unknown
Microarch®+	J72-242-00	FDA UDI	Class I	Unknown
In-Ovation ® Mini	191-332-10R	FDA UDI	Class I	Unknown
In-Ovation® C	100-311-00	FDA UDI	Class II	Unknown
Coballoy	03-616-04	FDA UDI	Class I	Unknown
Microarch®	72-122-03	FDA UDI	Class I	Unknown
Allure® Mb	101-142-14	FDA UDI	Class II	Unknown
Ovation S	410-121-00	FDA UDI	Class I	Unknown
Omniarch®	77-211-60	FDA UDI	Class I	Unknown
Microarch®+	J72-651-03	FDA UDI	Class I	Unknown
Omniarch®	77-541-04	FDA UDI	Class I	Unknown
Duraguard	DGSY040X25R	FDA UDI	U	Unknown
In-Ovation® R	189-122-08	FDA UDI	Class I	Unknown
Lowland	03-616-65T	FDA UDI	Class I	Unknown
Microarch®	72-111-10	FDA UDI	Class I	Unknown
Ovation S	410-332-10	FDA UDI	Class I	Unknown
Resolve Ceramic	CRPL318R	FDA UDI	Class I	Unknown
Sculpt I.Q.	6659184	FDA UDI	Class II	Unknown
In-Ovation® C	100-611-07	FDA UDI	Class II	Unknown
Bioforce®	02-628-541	FDA UDI	Class I	Unknown
In-Ovation® R	189-132-81	FDA UDI	Class I	Unknown
In-Ovation® R	189-431-60	FDA UDI	Class I	Unknown
In-Ovation® C	H100-232-00	FDA UDI	Class II	Unknown
Resolve® Ceramic	210-551-60	FDA UDI	Class II	Unknown
Omniarch®+	J77-232-10	FDA UDI	Class I	Unknown
Bioforce®	02-628-542	FDA UDI	Class I	Unknown
Round ultrafit	UFS040X10R	FDA UDI	U	Unknown
In-Ovation ® X	289-131-10	FDA UDI	Class I	Unknown
Omniarch®+	J77-442-60	FDA UDI	Class I	Unknown
In-Ovation® R	189-241-00	FDA UDI	Class I	Unknown
Omniarch®	77-332-04	FDA UDI	Class I	Unknown
Omniarch®	77-242-13	FDA UDI	Class I	Unknown
Microarch®	74-641-22	FDA UDI	Class I	Unknown
In-Ovation ® X	289-311-00	FDA UDI	Class I	Unknown
In-Ovation ® X	289-341-00	FDA UDI	Class I	Unknown
Mystique® Mb	110-232-91	FDA UDI	Class II	Unknown
Mystique® Mb	110-331-90	FDA UDI	Class II	Unknown
Mystique® Mb	110-242-90	FDA UDI	Class II	Unknown
Resolve® Ceramic	210-542-61	FDA UDI	Class II	Unknown
Ovation S	410-142-81	FDA UDI	Class I	Unknown
Resolve Ceramic	FRU118R	FDA UDI	Class II	Unknown
Lowland	03-012-54T	FDA UDI	Class I	Unknown
Square duraclear	DCS040X2S	FDA UDI	U	Unknown
Microarch®	72-441-60	FDA UDI	Class I	Unknown

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