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
At40	AT40	EUDAMED	Class I	Active
Evo Wp 14.2	EVO WP 14.2	EUDAMED	Class I	Active
Ansin206	ANSIN206	EUDAMED	Class I	Active
Biohss35	BIOHSS35	EUDAMED	Class I	Active
Klmulco30	KLMULCO30	EUDAMED	Class I	Active
Ansin047	ANSIN047	EUDAMED	Class I	Active
Ansin051	ANSIN051	EUDAMED	Class I	Active
061s	061S	EUDAMED	Class I	Active
Top Rp 115	TOP RP 115	EUDAMED	Class IIa	Active
Nanoti325	NANOTI325	EUDAMED	Class I	Active
Top S5 085	TOP S5 085	EUDAMED	Class IIa	Active
Camcmf33	CAMCMF33	EUDAMED	Class I	Active
Ansin224	ANSIN224	EUDAMED	Class I	Active
Ansin075	ANSIN075	EUDAMED	Class I	Active
203s	203S	EUDAMED	Class I	Active
Top S4 050	TOP S4 050	EUDAMED	Class IIa	Active
172.1104	172.1104	EUDAMED	Class I	Active
Ds36	DS36	EUDAMED	Class IIa	Active
181.0136	181.0136	EUDAMED	Class IIa	Active
133s	133S	EUDAMED	Class I	Active
Aurevodiwp	AUREVODIWP	EUDAMED	Class I	Active
071s	071S	EUDAMED	Class I	Active
179.0036	179.0036	EUDAMED	Class I	Active
Ansin093	ANSIN093	EUDAMED	Class I	Active
Tiologs	TIOLOGS	EUDAMED	Class I	Active
014s	014S	EUDAMED	Class I	Active
172.1001	172.1001	EUDAMED	Class I	Active
053.5200	053.5200	EUDAMED	Class I	Active
H16.2340	H16.2340	EUDAMED	Class I	Active
178.1330	178.1330	EUDAMED	Class IIa	Active
Aureadiwp	AUREADIWP	EUDAMED	Class I	Active
190.0002	190.0002	EUDAMED	Class I	Active
179.0028	179.0028	EUDAMED	Class I	Active
Mggano39	MGGANO39	EUDAMED	Class I	Active
Oseoxptxye	OSEOXPTXYE	EUDAMED	Class I	Active
154s.2	154S.2	EUDAMED	Class I	Active
176s	176S	EUDAMED	Class I	Active
Ds28	DS28	EUDAMED	Class IIa	Active
Top S23 100	TOP S23 100	EUDAMED	Class IIa	Active
Replnp	REPLNP	EUDAMED	Class I	Active
122s	122S	EUDAMED	Class I	Active
178.1328	178.1328	EUDAMED	Class IIa	Active
Evo Nr 27.1	EVO NR 27.1	EUDAMED	Class I	Active
Evo Np 02.2	EVO NP 02.2	EUDAMED	Class I	Active
179.0049	179.0049	EUDAMED	Class I	Active
012.5000	012.5000	EUDAMED	Class I	Active
An032	AN032	EUDAMED	Class I	Active
181.0333	181.0333	EUDAMED	Class IIa	Active
H12.3400	H12.3400	EUDAMED	Class I	Active
An014	AN014	EUDAMED	Class I	Active

Phibo Dental Solutions S.L.

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