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
Aurevopan	AUREVOPAN	EUDAMED	Class I	Active
Biohss45	BIOHSS45	EUDAMED	Class I	Active
An062	AN062	EUDAMED	Class I	Active
Avihe41	AVIHE41	EUDAMED	Class I	Active
178.0060	178.0060	EUDAMED	Class IIa	Active
174.1252	174.1252	EUDAMED	Class I	Active
Evo 01055	EVO 01055	EUDAMED	Class IIa	Active
H12.2000	H12.2000	EUDAMED	Class I	Active
Ds23	DS23	EUDAMED	Class IIa	Active
Ansin030	ANSIN030	EUDAMED	Class I	Active
Ndpilcm	NDPILCM	EUDAMED	Class I	Active
172.1101	172.1101	EUDAMED	Class I	Active
Adaurrp4	ADAURRP4	EUDAMED	Class I	Active
Active30	ACTIVE30	EUDAMED	Class I	Active
Octaco42	OCTACO42	EUDAMED	Class I	Active
064s	064S	EUDAMED	Class I	Active
Evo Rp 47.0	EVO RP 47.0	EUDAMED	Class I	Active
067s	067S	EUDAMED	Class I	Active
Evo 20000	EVO 20000	EUDAMED	Class IIa	Active
Ansin125	ANSIN125	EUDAMED	Class I	Active
Ansin203	ANSIN203	EUDAMED	Class I	Active
Ansin015	ANSIN015	EUDAMED	Class I	Active
Replrp	REPLRP	EUDAMED	Class I	Active
Prounicess3	PROUNICESS3	EUDAMED	Class I	Active
001s	001S	EUDAMED	Class I	Active
Ansin019	ANSIN019	EUDAMED	Class I	Active
017s	017S	EUDAMED	Class I	Active
178.1249	178.1249	EUDAMED	Class IIa	Active
011.5003	011.5003	EUDAMED	Class I	Active
Prounicpls5	PROUNICPLS5	EUDAMED	Class I	Active
Kitextlit	KITEXTLIT	EUDAMED	Class I	Active
Premkop38	PREMKOP38	EUDAMED	Class I	Active
152.0001	152.0001	EUDAMED	Class IIa	Active
033s	033S	EUDAMED	Class I	Active
178.1128	178.1128	EUDAMED	Class IIa	Active
Biot54	BIOT54	EUDAMED	Class I	Active
Ansin003	ANSIN003	EUDAMED	Class I	Active
Ansin184	ANSIN184	EUDAMED	Class I	Active
097s	097S	EUDAMED	Class I	Active
Ins35	INS35	EUDAMED	Class I	Active
Evo Wp 26.1	EVO WP 26.1	EUDAMED	Class I	Active
Ts 43000	TS 43000	EUDAMED	Class IIa	Active
Extern41	EXTERN41	EUDAMED	Class I	Active
Top Np 085	TOP NP 085	EUDAMED	Class IIa	Active
Biohss57	BIOHSS57	EUDAMED	Class I	Active
Top Rp48 085	TOP RP48 085	EUDAMED	Class IIa	Active
172.2302	172.2302	EUDAMED	Class I	Active
217s	217S	EUDAMED	Class I	Active
Adaurnp4	ADAURNP4	EUDAMED	Class I	Active
Top Rp48 115	TOP RP48 115	EUDAMED	Class IIa	Active

Phibo Dental Solutions S.L.

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