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
H15.2341	H15.2341	EUDAMED	Class I	Active
H24.2341	H24.2341	EUDAMED	Class I	Active
063.3000	063.3000	EUDAMED	Class I	Active
Top Wp 130	TOP WP 130	EUDAMED	Class IIa	Active
175.0001	175.0001	EUDAMED	Class IIa	Active
095s	095S	EUDAMED	Class I	Active
Ansin039	ANSIN039	EUDAMED	Class I	Active
Oseoxptli	OSEOXPTLI	EUDAMED	Class I	Active
Ansin062	ANSIN062	EUDAMED	Class I	Active
Klovgp	KLOVGP	EUDAMED	Class I	Active
Aurevopnp	AUREVOPNP	EUDAMED	Class I	Active
Top S5 050	TOP S5 050	EUDAMED	Class IIa	Active
213s	213S	EUDAMED	Class I	Active
H15.2340	H15.2340	EUDAMED	Class I	Active
Ansin121	ANSIN121	EUDAMED	Class I	Active
Ansin032	ANSIN032	EUDAMED	Class I	Active
034s	034S	EUDAMED	Class I	Active
178.1136	178.1136	EUDAMED	Class IIa	Active
Ansin021	ANSIN021	EUDAMED	Class I	Active
Zdswp48	ZDSWP48	EUDAMED	Class I	Active
048s	048S	EUDAMED	Class I	Active
Aureapwp	AUREAPWP	EUDAMED	Class I	Active
074s	074S	EUDAMED	Class I	Active
Ansin104	ANSIN104	EUDAMED	Class I	Active
Ansin168	ANSIN168	EUDAMED	Class I	Active
Evo Np 14.2	EVO NP 14.2	EUDAMED	Class I	Active
154s.3	154S.3	EUDAMED	Class I	Active
Ts 49000	TS 49000	EUDAMED	Class IIa	Active
An021	AN021	EUDAMED	Class I	Active
154s.1	154S.1	EUDAMED	Class I	Active
Evo 01035	EVO 01035	EUDAMED	Class IIa	Active
172.0300	172.0300	EUDAMED	Class I	Active
Biot44	BIOT44	EUDAMED	Class I	Active
104s	104S	EUDAMED	Class I	Active
121s	121S	EUDAMED	Class I	Active
178.0047	178.0047	EUDAMED	Class IIa	Active
Top S5 130	TOP S5 130	EUDAMED	Class IIa	Active
Ansin106	ANSIN106	EUDAMED	Class I	Active
204s	204S	EUDAMED	Class I	Active
Standrn	STANDRN	EUDAMED	Class I	Active
Evo Rp 02.0	EVO RP 02.0	EUDAMED	Class I	Active
Bioh57tap	BIOH57TAP	EUDAMED	Class I	Active
061.5000	061.5000	EUDAMED	Class I	Active
Ansin038	ANSIN038	EUDAMED	Class I	Active
Ziaoexrp	ZIAOEXRP	EUDAMED	Class I	Active
H24.5002	H24.5002	EUDAMED	Class I	Active
Ansin066	ANSIN066	EUDAMED	Class I	Active
Adaurrp2	ADAURRP2	EUDAMED	Class I	Active
178.1336	178.1336	EUDAMED	Class IIa	Active
Top S23 085	TOP S23 085	EUDAMED	Class IIa	Active

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