Question 1

What types of medical devices does Leone S.p.A. manufacture?

Accepted Answer

Leone S.p.A. specialises in dental medical devices, including rotary instruments used for drilling, cutting, and shaping teeth during procedures like restorative and endodontic treatments. They also produce dental implants designed for osseointegration in the jawbone, along with implant abutments and related components to support prosthetic restorations such as crowns, bridges, or dentures.

Question 2

Where is Leone S.p.A. based, and what does that mean for its devices?

Accepted Answer

Leone S.p.A. is headquartered in Italy, which means its devices are manufactured and regulated under the European Union’s medical device framework. This includes compliance with EU Medical Device Regulations (MDR) and registration in the EU’s eudamed database, ensuring traceability and transparency for authorised devices within the European Economic Area.

Question 3

Which regulatory registries list Leone S.p.A.’s devices?

Accepted Answer

Leone S.p.A.’s devices are listed in the eudamed database, the official EU registry for medical devices authorised for commercialisation within the European Economic Area. This database tracks device details, including manufacturer information, classifications, and regulatory status, ensuring transparency for healthcare professionals and regulators.

Question 4

How are Leone S.p.A.’s devices classified under EU regulations?

Accepted Answer

Leone S.p.A.’s devices are classified under the EU Medical Device Regulations (MDR) as Class I, Class IIa, or Class IIb, depending on their risk level and intended use. For example, dental rotary instruments may fall into lower-risk classes (e.g., Class I or IIa), while dental implants—due to their direct contact with bone and long-term use—are typically classified as Class IIb, reflecting their higher risk profile and stricter regulatory requirements.

Device	Model / Reference	Registries	Class	Status
Orthodontic Bands	E5105-09	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Bands	E8205-04	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Bands	E1300-03	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Brackets	G2489-15	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Tubes	F8485-902	EUDAMEDFDA UDI	Class IIa	Active
Wire products for fixed orthodontic appliance	C5952-16	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Brackets	F7182-02	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Bands	E1520-34	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Tubes	G8185-22	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Brackets	F4282-07	EUDAMEDFDA UDI	Class IIa	Active
Wire products for fixed orthodontic appliance	C5115-18	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Bands	E1535-20	EUDAMEDFDA UDI	Class IIa	Active
Wire products for fixed orthodontic appliance	C3250-18	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Bands	E8971-90	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Tubes	F8570-903	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Brackets	F6212-24	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Brackets	F7184C903	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Bands	E1520-28	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Brackets	F2870-900	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Bands	E1570-34	EUDAMEDFDA UDI	Class IIa	Active
Wire products for fixed orthodontic appliance	C5916-914	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Tubes	G8421-903	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Brackets	F4211-25	EUDAMEDFDA UDI	Class IIa	Active
Wire products for fixed orthodontic appliance	C5955-017	EUDAMEDFDA UDI	Class IIa	Active
Wire and preformed wire products for removable orthodontic appliance	C0585-48	EUDAMEDFDA UDI	Class I	Active
Abutments for Dental Implants	126-0010-33	EUDAMEDFDA UDI	Class IIb	Active
Orthodontic Bands	E1705-01	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic elastic chains and ligatures	K7351-10R	EUDAMEDFDA UDI	Class IIa	Active
Single-patient-use instruments and accessories	R3716-00	EUDAMEDFDA UDI	Class I	Active
Abutments for Dental Implants	126-2015-00	EUDAMEDFDA UDI	Class IIb	Active
Orthodontic Brackets	F4214-907	EUDAMEDFDA UDI	Class IIa	Active
Wire and preformed wire products for removable orthodontic appliance	C0450-07	EUDAMEDFDA UDI	Class I	Active
Orthodontic Brackets	F9020-915	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Brackets	F4510-913	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Bands	E1700-18	EUDAMEDFDA UDI	Class IIa	Active
Dental rotary instruments	156-0044-00	EUDAMED	Class IIa	Active
Orthodontic Brackets	F2085-901	EUDAMEDFDA UDI	Class IIa	Active
Thermoplastic and Thermoforming material	R7002-905	EUDAMEDFDA UDI	Class I	Active
Orthodontic Brackets	F7274-902	EUDAMEDFDA UDI	Class IIa	Active
Abutments for Dental Implants	129-4802-01	EUDAMEDFDA UDI	Class IIb	Active
Orthodontic Tubes	X0019	EUDAMEDFDA UDI	Class IIa	Active
Wire and preformed wire products for removable orthodontic appliance	C0585-31	EUDAMEDFDA UDI	Class I	Active
Extraoral device	X0032	EUDAMEDFDA UDI	Class I	Active
Orthodontic Brackets	F5181-903	EUDAMED	Class IIa	Active
Orthodontic Brackets	F5482-923	EUDAMED	Class IIa	Active
Orthodontic Brackets	F4410-914	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Bands	E8605-24	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Brackets	F2123E02	EUDAMEDFDA UDI	Class IIa	Active
Wire products for fixed orthodontic appliance	C0570-944	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Bands	E1705-34	EUDAMEDFDA UDI	Class IIa	Active

LEONE S.P.A.

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