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
016.4200	016.4200	EUDAMED	Class I	Active
Branenp	BRANENP	EUDAMED	Class I	Active
172.1105	172.1105	EUDAMED	Class I	Active
Ansin223	ANSIN223	EUDAMED	Class I	Active
H11.5002	H11.5002	EUDAMED	Class I	Active
Alpbio42	ALPBIO42	EUDAMED	Class I	Active
156s.3	156S.3	EUDAMED	Class I	Active
Ansin123	ANSIN123	EUDAMED	Class I	Active
Adaurwp	ADAURWP	EUDAMED	Class I	Active
Klovgrv	KLOVGRV	EUDAMED	Class I	Active
Evo Rp 14.1	EVO RP 14.1	EUDAMED	Class I	Active
172.1103	172.1103	EUDAMED	Class I	Active
Ziaoexnp	ZIAOEXNP	EUDAMED	Class I	Active
168s	168S	EUDAMED	Class I	Active
Ansin105	ANSIN105	EUDAMED	Class I	Active
Top S4 070	TOP S4 070	EUDAMED	Class IIa	Active
Activewp	ACTIVEWP	EUDAMED	Class I	Active
019s	019S	EUDAMED	Class I	Active
172s	172S	EUDAMED	Class I	Active
Top S4 085	TOP S4 085	EUDAMED	Class IIa	Active
Evo 01048	EVO 01048	EUDAMED	Class IIa	Active
Aureadirp	AUREADIRP	EUDAMED	Class I	Active
Adaurwp4	ADAURWP4	EUDAMED	Class I	Active
H15.2342	H15.2342	EUDAMED	Class I	Active
Ziaoexwp	ZIAOEXWP	EUDAMED	Class I	Active
Advs4	ADVS4	EUDAMED	Class I	Active
Premkop33	PREMKOP33	EUDAMED	Class I	Active
An033	AN033	EUDAMED	Class I	Active
178.0037	178.0037	EUDAMED	Class IIa	Active
Ds41	DS41	EUDAMED	Class IIa	Active
Msstd	MSSTD	EUDAMED	Class I	Active
Evo Np 47.0	EVO NP 47.0	EUDAMED	Class I	Active
Mlswi	MLSWI	EUDAMED	Class I	Active
H11.2002	H11.2002	EUDAMED	Class I	Active
038s	038S	EUDAMED	Class I	Active
Evo 44000	EVO 44000	EUDAMED	Class IIa	Active
Pad50	PAD50	EUDAMED	Class I	Active
Ansin004	ANSIN004	EUDAMED	Class I	Active
Certa34	CERTA34	EUDAMED	Class I	Active
Cam38	CAM38	EUDAMED	Class I	Active
053.4200	053.4200	EUDAMED	Class I	Active
155s	155S	EUDAMED	Class I	Active
172.1102	172.1102	EUDAMED	Class I	Active
Xphext41	XPHEXT41	EUDAMED	Class I	Active
Ansin132	ANSIN132	EUDAMED	Class I	Active
Conhexs2	CONHEXS2	EUDAMED	Class I	Active
Ext1it	EXT1IT	EUDAMED	Class I	Active
011.4004	011.4004	EUDAMED	Class I	Active
H38.5002	H38.5002	EUDAMED	Class I	Active
An031	AN031	EUDAMED	Class I	Active

Phibo Dental Solutions S.L.

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