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
Klovgmv	KLOVGMV	EUDAMED	Class I	Active
035s	035S	EUDAMED	Class I	Active
Alpbio50	ALPBIO50	EUDAMED	Class I	Active
011.4002	011.4002	EUDAMED	Class I	Active
Mswd	MSWD	EUDAMED	Class I	Active
032s	032S	EUDAMED	Class I	Active
011.3002	011.3002	EUDAMED	Class I	Active
Bioc52	BIOC52	EUDAMED	Class I	Active
Ansin172	ANSIN172	EUDAMED	Class I	Active
Tshs2	TSHS2	EUDAMED	Class I	Active
Tsas3	TSAS3	EUDAMED	Class I	Active
Ansin169	ANSIN169	EUDAMED	Class I	Active
139s	139S	EUDAMED	Class I	Active
Intern41	INTERN41	EUDAMED	Class I	Active
Ansin100	ANSIN100	EUDAMED	Class I	Active
Ansin204	ANSIN204	EUDAMED	Class I	Active
Biotbase	BIOTBASE	EUDAMED	Class I	Active
H18.3450	H18.3450	EUDAMED	Class I	Active
063.3030	063.3030	EUDAMED	Class I	Active
183s	183S	EUDAMED	Class I	Active
Top Rp 130	TOP RP 130	EUDAMED	Class IIa	Active
An108	AN108	EUDAMED	Class I	Active
Top Rp48 130	TOP RP48 130	EUDAMED	Class IIa	Active
Evo Np 26.1	EVO NP 26.1	EUDAMED	Class I	Active
Ansin139	ANSIN139	EUDAMED	Class I	Active
Premkodi425	PREMKODI425	EUDAMED	Class I	Active
Evo 00200	EVO 00200	EUDAMED	Class I	Active
Top S4 060	TOP S4 060	EUDAMED	Class IIa	Active
Ansin069	ANSIN069	EUDAMED	Class I	Active
Ansin054	ANSIN054	EUDAMED	Class I	Active
Evo Nr 48.2	EVO NR 48.2	EUDAMED	Class I	Active
173.0001	173.0001	EUDAMED	Class IIa	Active
101s	101S	EUDAMED	Class I	Active
Aureaprp	AUREAPRP	EUDAMED	Class I	Active
Ansin103	ANSIN103	EUDAMED	Class I	Active
011.3003	011.3003	EUDAMED	Class I	Active
Ansin071	ANSIN071	EUDAMED	Class I	Active
Scrvent35	SCRVENT35	EUDAMED	Class I	Active
Ansin023	ANSIN023	EUDAMED	Class I	Active
185s	185S	EUDAMED	Class I	Active
Inhex41	INHEX41	EUDAMED	Class I	Active
Aureadinp	AUREADINP	EUDAMED	Class I	Active
061.3000	061.3000	EUDAMED	Class I	Active
174.1251	174.1251	EUDAMED	Class I	Active
170s	170S	EUDAMED	Class I	Active
Adaurnp2	ADAURNP2	EUDAMED	Class I	Active
068s	068S	EUDAMED	Class I	Active
108s	108S	EUDAMED	Class I	Active
Top Np 130	TOP NP 130	EUDAMED	Class IIa	Active
Ansin135	ANSIN135	EUDAMED	Class I	Active

Phibo Dental Solutions S.L.

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