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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 7 of 70

Device	Model / Reference	Registries	Class	Status
Allure® Mb	101-541-04	FDA UDI	Class II	Unknown
Allure® Mb	101-222-14	FDA UDI	Class II	Unknown
In-Ovation® C	100-222-60	FDA UDI	Class II	Unknown
Resolve Ceramic	CS322	FDA UDI	Class I	Unknown
Allure® Mb	101-522-04	FDA UDI	Class II	Unknown
In-Ovation® R	189-122-00	FDA UDI	Class I	Unknown
Omniarch®	77-342-60	FDA UDI	Class I	Unknown
Ovation®	82-242-00	FDA UDI	Class I	Unknown
Spectra	03-020-21	FDA UDI	Class I	Unknown
Ovation®	82-342-00	FDA UDI	Class I	Unknown
In-Ovation® R	189-432-81	FDA UDI	Class I	Unknown
Duraguard	DGSR120X25S	FDA UDI	U	Unknown
In-Ovation® R	189-232-81	FDA UDI	Class I	Unknown
Omniarch®	77-452-13	FDA UDI	Class I	Unknown
Microarch®	72-652-33	FDA UDI	Class I	Unknown
In-Ovation ® Mini	191-442-81	FDA UDI	Class I	Unknown
Vistadent® Oc	27-311-70L	FDA UDI	Class II	Unknown
Microarch®+	J72-452-13	FDA UDI	Class I	Unknown
In-Ovation® C	H100-541-07	FDA UDI	Class II	Unknown
Omniarch®	77-222-70	FDA UDI	Class I	Unknown
In-Ovation® R	189-221-02	FDA UDI	Class I	Unknown
Sculpt I.Q.	6659226G	FDA UDI	Class II	Unknown
Duraclear	DCS060X10S	FDA UDI	U	Unknown
Lowland	03-014-40	FDA UDI	Class I	Unknown
In-Ovation® C	H100-121-07	FDA UDI	Class II	Unknown
Bioforce®	02-628-071	FDA UDI	Class I	Unknown
In-Ovation® R	189-222-60	FDA UDI	Class I	Unknown
Sentalloy®	02-000-00	FDA UDI	Class I	Unknown
Microarch®+	J72-122-60	FDA UDI	Class I	Unknown
Ovation®	83-141-00	FDA UDI	Class I	Unknown
Lowland	03-014-65T	FDA UDI	Class I	Unknown
Mystique® Mb	110-131-10	FDA UDI	Class II	Unknown
Microarch®+	J72-652-03	FDA UDI	Class I	Unknown
Microarch®	72-222-84	FDA UDI	Class I	Unknown
Microarch®	72-541-58	FDA UDI	Class I	Unknown
Resolve Ceramic	CRU222R	FDA UDI	Class I	Unknown
In-Ovation® R	189-242-00	FDA UDI	Class I	Unknown
Omniarch®	77-212-01	FDA UDI	Class I	Unknown
In-Ovation® C	H100-612-60	FDA UDI	Class II	Unknown
Ind Bonding Tray	DGINFC080X25S	FDA UDI	U	Unknown
Omniarch®	77-211-03	FDA UDI	Class I	Unknown
In-Ovation ® Mini	191-231-82R	FDA UDI	Class I	Unknown
Round ultrafit	UFS080X25R	FDA UDI	U	Unknown
In-Ovation® C	H100-331-60	FDA UDI	Class II	Unknown
In-Ovation® C	H100-212-80	FDA UDI	Class II	Unknown
Microarch®+	J72-332-13	FDA UDI	Class I	Unknown
Microarch®	72-551-51	FDA UDI	Class I	Unknown
Microarch®	72-542-60	FDA UDI	Class I	Unknown
Jeltrate Plus	605603G	FDA UDI	Class II	Unknown
Resolve Ceramic	FRU322L	FDA UDI	Class I	Unknown

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Emergo Europe B.V. NL

Importers

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Notified Bodies

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Authorities

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