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
009s	009S	EUDAMED	Class I	Active
219s	219S	EUDAMED	Class I	Active
173.1106	173.1106	EUDAMED	Class IIa	Active
Klesp25	KLESP25	EUDAMED	Class I	Active
H15.5002	H15.5002	EUDAMED	Class I	Active
Aurevoprp	AUREVOPRP	EUDAMED	Class I	Active
Ansin109	ANSIN109	EUDAMED	Class I	Active
Ansin205	ANSIN205	EUDAMED	Class I	Active
Ansin024	ANSIN024	EUDAMED	Class I	Active
216s	216S	EUDAMED	Class I	Active
Legacy35	LEGACY35	EUDAMED	Class I	Active
Ansin099	ANSIN099	EUDAMED	Class I	Active
Sem30	SEM30	EUDAMED	Class I	Active
Biot39	BIOT39	EUDAMED	Class I	Active
184s	184S	EUDAMED	Class I	Active
Top S5 115	TOP S5 115	EUDAMED	Class IIa	Active
172.0001	172.0001	EUDAMED	Class I	Active
An066	AN066	EUDAMED	Class I	Active
181.0342	181.0342	EUDAMED	Class IIa	Active
Sbx 00001	SBX 00001	EUDAMED	Class I	Active
An023	AN023	EUDAMED	Class I	Active
Bionherp	BIONHERP	EUDAMED	Class I	Active
Advs3	ADVS3	EUDAMED	Class I	Active
Aureapnp	AUREAPNP	EUDAMED	Class I	Active
Btimulim	BTIMULIM	EUDAMED	Class I	Active
100s	100S	EUDAMED	Class I	Active
Evo Np 03.0	EVO NP 03.0	EUDAMED	Class I	Active
Uniabut2035	UNIABUT2035	EUDAMED	Class I	Active
Top Rp48 145	TOP RP48 145	EUDAMED	Class IIa	Active
Ansin020	ANSIN020	EUDAMED	Class I	Active
Aurevodirp48	AUREVODIRP48	EUDAMED	Class I	Active
Ansin063	ANSIN063	EUDAMED	Class I	Active
Ziaoinrw	ZIAOINRW	EUDAMED	Class I	Active
Ansin175	ANSIN175	EUDAMED	Class I	Active
Top S4 115	TOP S4 115	EUDAMED	Class IIa	Active
Oseoxpco50	OSEOXPCO50	EUDAMED	Class I	Active
Ansin153	ANSIN153	EUDAMED	Class I	Active
Premkop5	PREMKOP5	EUDAMED	Class I	Active
181.0336	181.0336	EUDAMED	Class IIa	Active
011.3005	011.3005	EUDAMED	Class I	Active
H15.2343	H15.2343	EUDAMED	Class I	Active
Ansin033	ANSIN033	EUDAMED	Class I	Active
Top S23 050	TOP S23 050	EUDAMED	Class IIa	Active
H38.2002	H38.2002	EUDAMED	Class I	Active
021s	021S	EUDAMED	Class I	Active
Ansin007	ANSIN007	EUDAMED	Class I	Active
Evo Rp 18.0	EVO RP 18.0	EUDAMED	Class I	Active
Evo 00001	EVO 00001	EUDAMED	Class I	Active
152.0002	152.0002	EUDAMED	Class IIa	Active
Top Wp 115	TOP WP 115	EUDAMED	Class IIa	Active

Phibo Dental Solutions S.L.

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