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
Sem325	SEM325	EUDAMED	Class I	Active
006s	006S	EUDAMED	Class I	Active
011.4003	011.4003	EUDAMED	Class I	Active
167s	167S	EUDAMED	Class I	Active
Ins50	INS50	EUDAMED	Class I	Active
Top S23 115	TOP S23 115	EUDAMED	Class IIa	Active
Tshs34	TSHS34	EUDAMED	Class I	Active
Tshs5	TSHS5	EUDAMED	Class I	Active
Mcstdr	MCSTDR	EUDAMED	Class I	Active
Ansin219	ANSIN219	EUDAMED	Class I	Active
180s	180S	EUDAMED	Class I	Active
Ansin111	ANSIN111	EUDAMED	Class I	Active
Ndcmo	NDCMO	EUDAMED	Class I	Active
Mggano43	MGGANO43	EUDAMED	Class I	Active
011.5001	011.5001	EUDAMED	Class I	Active
Branewp	BRANEWP	EUDAMED	Class I	Active
Ansin006	ANSIN006	EUDAMED	Class I	Active
Ansin170	ANSIN170	EUDAMED	Class I	Active
Deprostd	DEPROSTD	EUDAMED	Class I	Active
An039	AN039	EUDAMED	Class I	Active
An016	AN016	EUDAMED	Class I	Active
181.0142	181.0142	EUDAMED	Class IIa	Active
Xive38	XIVE38	EUDAMED	Class I	Active
031s	031S	EUDAMED	Class I	Active
Argen42	ARGEN42	EUDAMED	Class I	Active
016s	016S	EUDAMED	Class I	Active
H12.5000	H12.5000	EUDAMED	Class I	Active
Ansin102	ANSIN102	EUDAMED	Class I	Active
103s	103S	EUDAMED	Class I	Active
Ts 23000	TS 23000	EUDAMED	Class IIa	Active
Etknat30	ETKNAT30	EUDAMED	Class I	Active
179.0041	179.0041	EUDAMED	Class I	Active
Bionhisp	BIONHISP	EUDAMED	Class I	Active
Adaurwp1	ADAURWP1	EUDAMED	Class I	Active
Scrvent45	SCRVENT45	EUDAMED	Class I	Active
172.1252	172.1252	EUDAMED	Class I	Active
011.5002	011.5002	EUDAMED	Class I	Active
070s	070S	EUDAMED	Class I	Active
153s	153S	EUDAMED	Class I	Active
H24.2342	H24.2342	EUDAMED	Class I	Active
Top Rp 100	TOP RP 100	EUDAMED	Class IIa	Active
062s	062S	EUDAMED	Class I	Active
Bonledinc	BONLEDINC	EUDAMED	Class I	Active
Ansin097	ANSIN097	EUDAMED	Class I	Active
202s	202S	EUDAMED	Class I	Active
167s	167S	EUDAMED	Class I	Active
041s	041S	EUDAMED	Class I	Active
172.0172	172.0172	EUDAMED	Class I	Active
Ansin068	ANSIN068	EUDAMED	Class I	Active
177.0000	177.0000	EUDAMED	Class I	Active

Phibo Dental Solutions S.L.

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