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
173.1252	173.1252	EUDAMED	Class IIa	Active
Zdpcon	ZDPCON	EUDAMED	Class I	Active
Sem45	SEM45	EUDAMED	Class I	Active
Extern55	EXTERN55	EUDAMED	Class I	Active
174.1001	174.1001	EUDAMED	Class I	Active
Blmult65	BLMULT65	EUDAMED	Class I	Active
Ins40	INS40	EUDAMED	Class I	Active
Ansin131	ANSIN131	EUDAMED	Class I	Active
156s.1	156S.1	EUDAMED	Class I	Active
173.1251	173.1251	EUDAMED	Class IIa	Active
003s	003S	EUDAMED	Class I	Active
Top Rp 085	TOP RP 085	EUDAMED	Class IIa	Active
053.4100	053.4100	EUDAMED	Class I	Active
008s	008S	EUDAMED	Class I	Active
004s	004S	EUDAMED	Class I	Active
Evo Rp 14.2	EVO RP 14.2	EUDAMED	Class I	Active
Ds43	DS43	EUDAMED	Class IIa	Active
Top Rp 145	TOP RP 145	EUDAMED	Class IIa	Active
022s	022S	EUDAMED	Class I	Active
Adaurwp3	ADAURWP3	EUDAMED	Class I	Active
018.4000	018.4000	EUDAMED	Class I	Active
Evo Rp 03.0	EVO RP 03.0	EUDAMED	Class I	Active
Btiunit	BTIUNIT	EUDAMED	Class I	Active
172.1002	172.1002	EUDAMED	Class I	Active
Ansin042	ANSIN042	EUDAMED	Class I	Active
Evo Np 18.0	EVO NP 18.0	EUDAMED	Class I	Active
053.5100	053.5100	EUDAMED	Class I	Active
155s.2	155S.2	EUDAMED	Class I	Active
Tsarotas3	TSAROTAS3	EUDAMED	Class I	Active
002s	002S	EUDAMED	Class I	Active
H24.5001	H24.5001	EUDAMED	Class I	Active
H38.5001	H38.5001	EUDAMED	Class I	Active
An106	AN106	EUDAMED	Class I	Active
Ansin166	ANSIN166	EUDAMED	Class I	Active
Camcon38	CAMCON38	EUDAMED	Class I	Active
123s	123S	EUDAMED	Class I	Active
Blmult450	BLMULT450	EUDAMED	Class I	Active
047s	047S	EUDAMED	Class I	Active
063.4010	063.4010	EUDAMED	Class I	Active
Legacy45	LEGACY45	EUDAMED	Class I	Active
173.0100	173.0100	EUDAMED	Class IIa	Active
Ostpe	OSTPE	EUDAMED	Class I	Active
005s	005S	EUDAMED	Class I	Active
Ansin221	ANSIN221	EUDAMED	Class I	Active
Ansin074	ANSIN074	EUDAMED	Class I	Active
Ansin209	ANSIN209	EUDAMED	Class I	Active
Standwn	STANDWN	EUDAMED	Class I	Active
Mcwd	MCWD	EUDAMED	Class I	Active
174.1253	174.1253	EUDAMED	Class I	Active
Ansin101	ANSIN101	EUDAMED	Class I	Active

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