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
Prounicpls4	PROUNICPLS4	EUDAMED	Class I	Active
Semmini	SEMMINI	EUDAMED	Class I	Active
156s.2	156S.2	EUDAMED	Class I	Active
Evo Nw 19.0	EVO NW 19.0	EUDAMED	Class I	Active
Bionhirp	BIONHIRP	EUDAMED	Class I	Active
172.1251	172.1251	EUDAMED	Class I	Active
176.1323	176.1323	EUDAMED	Class IIa	Active
Evo Wp 47.0	EVO WP 47.0	EUDAMED	Class I	Active
018.3000	018.3000	EUDAMED	Class I	Active
An015	AN015	EUDAMED	Class I	Active
Ansin094	ANSIN094	EUDAMED	Class I	Active
Ext2it	EXT2IT	EUDAMED	Class I	Active
System40	SYSTEM40	EUDAMED	Class I	Active
Evo Rw 02.2	EVO RW 02.2	EUDAMED	Class I	Active
092s	092S	EUDAMED	Class I	Active
063s	063S	EUDAMED	Class I	Active
Camcmf50	CAMCMF50	EUDAMED	Class I	Active
H24.2345	H24.2345	EUDAMED	Class I	Active
156s.4	156S.4	EUDAMED	Class I	Active
066s	066S	EUDAMED	Class I	Active
018.5000	018.5000	EUDAMED	Class I	Active
Branerp	BRANERP	EUDAMED	Class I	Active
System50	SYSTEM50	EUDAMED	Class I	Active
Aviuni41	AVIUNI41	EUDAMED	Class I	Active
155s.4	155S.4	EUDAMED	Class I	Active
154s.4	154S.4	EUDAMED	Class I	Active
174.2301	174.2301	EUDAMED	Class I	Active
078s	078S	EUDAMED	Class I	Active
166s	166S	EUDAMED	Class I	Active
Xive34	XIVE34	EUDAMED	Class I	Active
Ecktr	ECKTR	EUDAMED	Class I	Active
Top S23 145	TOP S23 145	EUDAMED	Class IIa	Active
Etknatdi	ETKNATDI	EUDAMED	Class I	Active
155s.1	155S.1	EUDAMED	Class I	Active
Ndpcon	NDPCON	EUDAMED	Class I	Active
H11.5001	H11.5001	EUDAMED	Class I	Active
Ansin022	ANSIN022	EUDAMED	Class I	Active
190.0018	190.0018	EUDAMED	Class IIa	Active
Adaurrp3	ADAURRP3	EUDAMED	Class I	Active
An131	AN131	EUDAMED	Class I	Active
H11.2001	H11.2001	EUDAMED	Class I	Active
Ansin092	ANSIN092	EUDAMED	Class I	Active
Ansin185	ANSIN185	EUDAMED	Class I	Active
Ansin220	ANSIN220	EUDAMED	Class I	Active
Klovgnv	KLOVGNV	EUDAMED	Class I	Active
179.0030	179.0030	EUDAMED	Class I	Active
223s	223S	EUDAMED	Class I	Active
130s	130S	EUDAMED	Class I	Active
Ansin064	ANSIN064	EUDAMED	Class I	Active
Adaurrp1	ADAURRP1	EUDAMED	Class I	Active

Phibo Dental Solutions S.L.

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