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
H18.2000	H18.2000	EUDAMED	Class I	Active
Zdeztetic	ZDEZTETIC	EUDAMED	Class I	Active
Ext3it	EXT3IT	EUDAMED	Class I	Active
171s	171S	EUDAMED	Class I	Active
An024	AN024	EUDAMED	Class I	Active
Evo 01043	EVO 01043	EUDAMED	Class IIa	Active
Univer50	UNIVER50	EUDAMED	Class I	Active
Ansin002	ANSIN002	EUDAMED	Class I	Active
190.0016	190.0016	EUDAMED	Class IIa	Active
Essenti42	ESSENTI42	EUDAMED	Class I	Active
Top S23 130	TOP S23 130	EUDAMED	Class IIa	Active
Ansin014	ANSIN014	EUDAMED	Class I	Active
Ts 30000	TS 30000	EUDAMED	Class IIa	Active
030s	030S	EUDAMED	Class I	Active
Aurevopwp	AUREVOPWP	EUDAMED	Class I	Active
Bioh30las	BIOH30LAS	EUDAMED	Class I	Active
Top Wp 085	TOP WP 085	EUDAMED	Class IIa	Active
Synoctwn	SYNOCTWN	EUDAMED	Class I	Active
011.4001	011.4001	EUDAMED	Class I	Active
Ts 41000	TS 41000	EUDAMED	Class IIa	Active
Ansin017	ANSIN017	EUDAMED	Class I	Active
Ansin079	ANSIN079	EUDAMED	Class I	Active
Repl60	REPL60	EUDAMED	Class I	Active
178.1241	178.1241	EUDAMED	Class IIa	Active
110s	110S	EUDAMED	Class I	Active
098s	098S	EUDAMED	Class I	Active
106s	106S	EUDAMED	Class I	Active
Ansin176	ANSIN176	EUDAMED	Class I	Active
178.1130	178.1130	EUDAMED	Class IIa	Active
094s	094S	EUDAMED	Class I	Active
Prounicpls3	PROUNICPLS3	EUDAMED	Class I	Active
An105	AN105	EUDAMED	Class I	Active
Ansin208	ANSIN208	EUDAMED	Class I	Active
H38.3401	H38.3401	EUDAMED	Class I	Active
135s	135S	EUDAMED	Class I	Active
063.4000	063.4000	EUDAMED	Class I	Active
Premkodi33	PREMKODI33	EUDAMED	Class I	Active
Top S23 060	TOP S23 060	EUDAMED	Class IIa	Active
Ansin036	ANSIN036	EUDAMED	Class I	Active
Conhexs5	CONHEXS5	EUDAMED	Class I	Active
Ansin110	ANSIN110	EUDAMED	Class I	Active
Evo Wp 14.1	EVO WP 14.1	EUDAMED	Class I	Active
051s	051S	EUDAMED	Class I	Active
Tiologm	TIOLOGM	EUDAMED	Class I	Active
Osseus41	OSSEUS41	EUDAMED	Class I	Active
Synoctrn	SYNOCTRN	EUDAMED	Class I	Active
Top S5 060	TOP S5 060	EUDAMED	Class IIa	Active
Tsas4	TSAS4	EUDAMED	Class I	Active
Chan	CHAN	EUDAMED	Class I	Active
169s	169S	EUDAMED	Class I	Active

Phibo Dental Solutions S.L.

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