Question 1

What types of medical devices does Phibo Dental Solutions S.L. manufacture?

Accepted Answer

Phibo Dental Solutions S.L. specializes in reusable surgical screwdrivers, which are primarily used in dental procedures. These tools are designed for precision tasks such as implantology and restorative dentistry, ensuring secure and controlled placement of dental components. Examples include models like 167S, ADAURNP3, and 093S.

Question 2

Where is Phibo Dental Solutions S.L. based?

Accepted Answer

The company is headquartered in Spain, specifically in the region of Catalonia. Its location in the EU ensures compliance with regional regulatory standards for medical devices, including those used in dental surgery.

Question 3

Which EU regulatory registries list Phibo Dental Solutions S.L.’s devices?

Accepted Answer

All of Phibo Dental Solutions S.L.’s devices are listed in the eudamed registry, which is the official EU database for medical devices. This registry is maintained under the EU Medical Device Regulations (MDR) to track authorized products across the European market.

Question 4

How are Phibo Dental Solutions S.L.’s devices classified under EU regulations?

Accepted Answer

The company’s devices fall under Class I and Class IIa classifications according to the EU Medical Device Regulations. This classification is determined by factors like the device’s risk level, intended use, and potential impact on patient safety. Surgical screwdrivers like those produced by Phibo are typically classified as Class IIa due to their role in critical dental procedures.

Device	Model / Reference	Registries	Class	Status
053.3100	053.3100	EUDAMED	Class I	Active
076s	076S	EUDAMED	Class I	Active
Camcon33	CAMCON33	EUDAMED	Class I	Active
Evo Rp 26.1	EVO RP 26.1	EUDAMED	Class I	Active
Blncmult35	BLNCMULT35	EUDAMED	Class I	Active
176.1123	176.1123	EUDAMED	Class IIa	Active
Adaurwp2	ADAURWP2	EUDAMED	Class I	Active
An067	AN067	EUDAMED	Class I	Active
Trasnep45	TRASNEP45	EUDAMED	Class I	Active
016.5100	016.5100	EUDAMED	Class I	Active
Oseoti50	OSEOTI50	EUDAMED	Class I	Active
Legacy30	LEGACY30	EUDAMED	Class I	Active
Multiuwp	MULTIUWP	EUDAMED	Class I	Active
Evo Np 14.1	EVO NP 14.1	EUDAMED	Class I	Active
Ansin067	ANSIN067	EUDAMED	Class I	Active
Ansin078	ANSIN078	EUDAMED	Class I	Active
H15.5001	H15.5001	EUDAMED	Class I	Active
016.3200	016.3200	EUDAMED	Class I	Active
Top S4 145	TOP S4 145	EUDAMED	Class IIa	Active
012.4000	012.4000	EUDAMED	Class I	Active
Activenp	ACTIVENP	EUDAMED	Class I	Active
H38.3402	H38.3402	EUDAMED	Class I	Active
Ansin183	ANSIN183	EUDAMED	Class I	Active
042s	042S	EUDAMED	Class I	Active
Ts 36000	TS 36000	EUDAMED	Class IIa	Active
172.2301	172.2301	EUDAMED	Class I	Active
Ext4it	EXT4IT	EUDAMED	Class I	Active
Certa41	CERTA41	EUDAMED	Class I	Active
Ds00	DS00	EUDAMED	Class IIa	Active
H11.3402	H11.3402	EUDAMED	Class I	Active
Evo Wp 18.0	EVO WP 18.0	EUDAMED	Class I	Active
Depronr	DEPRONR	EUDAMED	Class I	Active
Tbrcon	TBRCON	EUDAMED	Class I	Active
Zdswp38	ZDSWP38	EUDAMED	Class I	Active
Evo 23000	EVO 23000	EUDAMED	Class IIa	Active
181.0248	181.0248	EUDAMED	Class IIa	Active
Ansin048	ANSIN048	EUDAMED	Class I	Active
Platin50	PLATIN50	EUDAMED	Class I	Active
Dynocto	DYNOCTO	EUDAMED	Class I	Active
Ansin207	ANSIN207	EUDAMED	Class I	Active
Ansin182	ANSIN182	EUDAMED	Class I	Active
Replwp	REPLWP	EUDAMED	Class I	Active
063.4030	063.4030	EUDAMED	Class I	Active
Ansin041	ANSIN041	EUDAMED	Class I	Active
H38.2001	H38.2001	EUDAMED	Class I	Active
173.0300	173.0300	EUDAMED	Class IIa	Active
109s	109S	EUDAMED	Class I	Active
099s	099S	EUDAMED	Class I	Active
Extc4it	EXTC4IT	EUDAMED	Class I	Active
Bonlesranc	BONLESRANC	EUDAMED	Class I	Active

Phibo Dental Solutions S.L.

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