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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 1 of 70

Device	Model / Reference	Registries	Class	Status
Ovation®	03-622-643	FDA UDI	Class I	Unknown
Resolve® Ceramic	210-212-00	FDA UDI	Class II	Unknown
Ovation®	82-122-10	FDA UDI	Class I	Unknown
Ovation® C EURO	310-612-80	FDA UDI	Class II	Unknown
Essix A+	11020-SH	FDA UDI	Class II	Unknown
In-Ovation® C	H100-132-61	FDA UDI	Class II	Unknown
In-Ovation® R	189-442-61	FDA UDI	Class I	Unknown
Microarch®	72-641-58	FDA UDI	Class I	Unknown
Omniarch®	76-541-03	FDA UDI	Class I	Unknown
Generus® Ii	31-111-80	FDA UDI	Class I	Unknown
Essix	1MEDL125	FDA UDI	U	Active
Mtm®	82IKIT	FDA UDI	Class II	Unknown
Microarch®	72-221-02	FDA UDI	Class I	Unknown
Omniarch®	77-241-71	FDA UDI	Class I	Unknown
In-Ovation® R	189-131-60	FDA UDI	Class I	Unknown
In-Ovation® C	H100-542-07	FDA UDI	Class II	Unknown
Sculpt I.Q.	6659291G	FDA UDI	Class II	Unknown
Omniarch®	77-151-10	FDA UDI	Class I	Unknown
Resolve Ceramic	FRL318RHK	FDA UDI	Class II	Unknown
In-Ovation® R	189-242-13	FDA UDI	Class I	Unknown
In-Ovation® R	189-232-41	FDA UDI	Class I	Unknown
Microarch®+	J72-211-00	FDA UDI	Class I	Unknown
Square ultrafit	UFS040X10SS	FDA UDI	U	Unknown
Omniarch®	77-222-91	FDA UDI	Class I	Unknown
Omniarch®	77-141-91	FDA UDI	Class I	Unknown
Ovation S	410-641-80	FDA UDI	Class I	Unknown
Posterior Lower Pontic	PLMO-G	FDA UDI	Class II	Active
Microarch®	72-331-13	FDA UDI	Class I	Unknown
Microarch®+	J72-542-60	FDA UDI	Class I	Unknown
Microarch®	73-241-10	FDA UDI	Class I	Unknown
Microarch®	74-031-22	FDA UDI	Class I	Unknown
Omniarch®	77-121-70	FDA UDI	Class I	Unknown
In-Ovation® C	K100-551-81	FDA UDI	Class II	Unknown
Duraguard	DGSW120X25R	FDA UDI	U	Unknown
Microarch®+	J72-341-23	FDA UDI	Class I	Unknown
Microarch®+	J72-441-23	FDA UDI	Class I	Unknown
Omniarch®	76-232-10	FDA UDI	Class I	Unknown
Mini Ovation®	85-412-00	FDA UDI	Class I	Unknown
Omniarch®+	J77-212-00	FDA UDI	Class I	Unknown
Ovation®	82-132-11	FDA UDI	Class I	Unknown
Duraguard	DGSC160X25R	FDA UDI	U	Unknown
Bioforce®	02-628-592	FDA UDI	Class I	Unknown
In-Ovation® R	189-131-00	FDA UDI	Class I	Unknown
Resolve Ceramic	CRPL318LHK	FDA UDI	Class I	Unknown
Resolve® Ceramic	210-221-60	FDA UDI	Class II	Unknown
Neo Sentalloy®	02-623-642	FDA UDI	Class I	Unknown
Ovation®	82-131-16	FDA UDI	Class I	Unknown
Composite	FRL118TWN	FDA UDI	Class II	Unknown
In-Ovation® R	189-432-12	FDA UDI	Class I	Unknown
Ovation®	03-014-652	FDA UDI	Class I	Unknown

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