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
011.5004	011.5004	EUDAMED	Class I	Active
Ansin202	ANSIN202	EUDAMED	Class I	Active
H11.3401	H11.3401	EUDAMED	Class I	Active
182s	182S	EUDAMED	Class I	Active
Evo Rp48 03.0	EVO RP48 03.0	EUDAMED	Class I	Active
Ansin035	ANSIN035	EUDAMED	Class I	Active
218s	218S	EUDAMED	Class I	Active
132s	132S	EUDAMED	Class I	Active
Top S4 100	TOP S4 100	EUDAMED	Class IIa	Active
Evo 34000	EVO 34000	EUDAMED	Class IIa	Active
181.0133	181.0133	EUDAMED	Class IIa	Active
Ansin008	ANSIN008	EUDAMED	Class I	Active
Intern55	INTERN55	EUDAMED	Class I	Active
Bioc40	BIOC40	EUDAMED	Class I	Active
Premkodi38	PREMKODI38	EUDAMED	Class I	Active
Ansin077	ANSIN077	EUDAMED	Class I	Active
An038	AN038	EUDAMED	Class I	Active
063.5000	063.5000	EUDAMED	Class I	Active
Bioh35tap	BIOH35TAP	EUDAMED	Class I	Active
016.3100	016.3100	EUDAMED	Class I	Active
Evo 54000	EVO 54000	EUDAMED	Class IIa	Active
155s.3	155S.3	EUDAMED	Class I	Active
H15.5000	H15.5000	EUDAMED	Class I	Active
173.1001	173.1001	EUDAMED	Class IIa	Active
Ins60	INS60	EUDAMED	Class I	Active
Ndhedi41	NDHEDI41	EUDAMED	Class I	Active
Ansin016	ANSIN016	EUDAMED	Class I	Active
Cam33	CAM33	EUDAMED	Class I	Active
Top Rp48 100	TOP RP48 100	EUDAMED	Class IIa	Active
Ansin122	ANSIN122	EUDAMED	Class I	Active
An020	AN020	EUDAMED	Class I	Active
Evo Nr 48.1	EVO NR 48.1	EUDAMED	Class I	Active
174.1002	174.1002	EUDAMED	Class I	Active
190.0020	190.0020	EUDAMED	Class IIa	Active
Ansin009	ANSIN009	EUDAMED	Class I	Active
Activerp	ACTIVERP	EUDAMED	Class I	Active
105s	105S	EUDAMED	Class I	Active
016.4100	016.4100	EUDAMED	Class I	Active
Evo 52052	EVO 52052	EUDAMED	Class IIa	Active
172.1100	172.1100	EUDAMED	Class I	Active
Ansin061	ANSIN061	EUDAMED	Class I	Active
Ansin076	ANSIN076	EUDAMED	Class I	Active
Prounicess4	PROUNICESS4	EUDAMED	Class I	Active
Msnrw	MSNRW	EUDAMED	Class I	Active
Ansin222	ANSIN222	EUDAMED	Class I	Active
An018	AN018	EUDAMED	Class I	Active
Aurevodirp	AUREVODIRP	EUDAMED	Class I	Active
Ansin018	ANSIN018	EUDAMED	Class I	Active
Llmancc4it	LLMANCC4IT	EUDAMED	Class I	Active
Ansin031	ANSIN031	EUDAMED	Class I	Active

Phibo Dental Solutions S.L.

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