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
Certain34	CERTAIN34	EUDAMED	Class I	Active
173.1002	173.1002	EUDAMED	Class IIa	Active
Iridium35	IRIDIUM35	EUDAMED	Class I	Active
Top S5 100	TOP S5 100	EUDAMED	Class IIa	Active
An017	AN017	EUDAMED	Class I	Active
Evo Np 02.0	EVO NP 02.0	EUDAMED	Class I	Active
Ansin098	ANSIN098	EUDAMED	Class I	Active
Bonlesrarc	BONLESRARC	EUDAMED	Class I	Active
053.3200	053.3200	EUDAMED	Class I	Active
179.0043	179.0043	EUDAMED	Class I	Active
Tsarotas4	TSAROTAS4	EUDAMED	Class I	Active
Evo 41000	EVO 41000	EUDAMED	Class IIa	Active
011.3004	011.3004	EUDAMED	Class I	Active
Cam50	CAM50	EUDAMED	Class I	Active
181.0255	181.0255	EUDAMED	Class IIa	Active
079s	079S	EUDAMED	Class I	Active
023s	023S	EUDAMED	Class I	Active
Alpbio60	ALPBIO60	EUDAMED	Class I	Active
Ds30	DS30	EUDAMED	Class IIa	Active
Ansin095	ANSIN095	EUDAMED	Class I	Active
016.5200	016.5200	EUDAMED	Class I	Active
Camcon50	CAMCON50	EUDAMED	Class I	Active
Advs5	ADVS5	EUDAMED	Class I	Active
Premkodi50	PREMKODI50	EUDAMED	Class I	Active
Ansin070	ANSIN070	EUDAMED	Class I	Active
Top S5 070	TOP S5 070	EUDAMED	Class IIa	Active
063.4020	063.4020	EUDAMED	Class I	Active
Premkop425	PREMKOP425	EUDAMED	Class I	Active
007s	007S	EUDAMED	Class I	Active
Top S4 130	TOP S4 130	EUDAMED	Class IIa	Active
Ansin034	ANSIN034	EUDAMED	Class I	Active
Adaurrp	ADAURRP	EUDAMED	Class I	Active
Ndhedi33	NDHEDI33	EUDAMED	Class I	Active
Certa50	CERTA50	EUDAMED	Class I	Active
Ansin171	ANSIN171	EUDAMED	Class I	Active
Friadpilmp	FRIADPILMP	EUDAMED	Class I	Active
Biot36	BIOT36	EUDAMED	Class I	Active
063.5010	063.5010	EUDAMED	Class I	Active
H16.5000	H16.5000	EUDAMED	Class I	Active
Anaur	ANAUR	EUDAMED	Class I	Active
178s	178S	EUDAMED	Class I	Active
Top Wp 100	TOP WP 100	EUDAMED	Class IIa	Active
111s	111S	EUDAMED	Class I	Active
Oseoxptxaq	OSEOXPTXAQ	EUDAMED	Class I	Active
Bionhewp	BIONHEWP	EUDAMED	Class I	Active
Multiunprp	MULTIUNPRP	EUDAMED	Class I	Active
063.3010	063.3010	EUDAMED	Class I	Active
Ansin167	ANSIN167	EUDAMED	Class I	Active
054s	054S	EUDAMED	Class I	Active
175s	175S	EUDAMED	Class I	Active

Phibo Dental Solutions S.L.

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