Manufacturer

Cefla

ItalyLegal entities : CEFLA s.c.

Markets : Italy · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 23 · class I, II · latest in 2026 · see on the FDA website

Website

16 categories, 36 models including 36 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Tartar ablators	Z12119001	Piezolight 6 piezoelectric scaler93/42 Piezosteril 6 Piezoelectric scalers93/42 SC-A2 Piezoelectric scaler93/42 SC-A3 piezoelectric scaler93/42 SC-S4 piezoelectric scaler93/42 5 others Surgison 2 piezoelectric scaler93/42 Surgison 2D piezoelectric scaler93/42 u-PZ6 Piezoelectric scaler93/42 u-PZ7 piezoelectric scaler93/42 u-PZ8 piezoelectric scaler93/42	IIa 93/42	EUDAMED record Report an error
Instruments for dental treatment units - hardware accessories	Z12110180	Goldspeed Evo D1 Dental handpieces and contra-angles3 refs Silent Power Evo 2 Dental turbines93/42 Silent Power Evo 2L Dental turbines93/42 Silent Power Evo 4L Dental turbines93/42 Silent Power Evo 4LK Dental turbines93/42 2 others Silent Power Evo Miniature Dental turbines93/42 Silent Power Evo Miniature K Dental turbines93/42	IIa MDR, 93/42	EUDAMED record Report an error
Laser imaging scanner	Z110601	3Di IOS Intraoral scanner3 refs DXPS Devices for recording X-ray imaging for intra oral images93/42 hy-scan Devices for recording X-ray imaging for intra oral images2 refs93/42 X-PSP Devices for recording X-ray imaging for intra oral images6 refs93/42	I, IIa MDR, 93/42	EUDAMED record Report an error
Cleaning and disinfection equipment	Z12011301	ARX CLEAN evo Washer-disinfectors employing thermal disinfection and/or ultrasound, for medical purpose3 refs C.D.L. 4 Washer-disinfector for dental instruments2 refs	IIb MDR	EUDAMED record Report an error
Computed tomographs (CT) - other	Z11030699	NewTom 5G XL2 refs NewTom VGi evo Computed tomograph for dental radiology	IIb MDR	EUDAMED record Report an error
Cold light dental equipment	Z12119003	T-LED Curing light3 refs	I MDR	EUDAMED record Report an error
Dental cleaning/washing handpiece equipments	Z12119006	Thalya Devices for lubrication of dental instruments	I MDR	EUDAMED record Report an error
Dental treatment units	Z12110101	A3 PLUS3 refs	IIa MDR	EUDAMED record Report an error
Equipment for conventional endoral radiology	Z1103040101	RX DC Dental intraoral x-ray equipment3 refs	IIb MDR	EUDAMED record Report an error
Equipment for extraoral dental radiology, digital	Z1103030102	Core 1000 Panoramic, cephalometric and tomographic X-ray equipment3 refs	IIb MDR	EUDAMED record Report an error
Fixed scialytic lamps	Z12010701	VENUS PLUS Operating light3 refs	I MDR	EUDAMED record Report an error
Instruments for endoral radiology - consumables	Z11030480	AX-DCiS Digital radiograpy sensors3 refs	IIa MDR	EUDAMED record Report an error
Small load autoclaves with a chamber smaller than 1 standard sterilisation unit	Z12011305	A-17 Steam sterilizing units3 refs	IIb MDR	EUDAMED record Report an error
Surgical cameras	Z12020405	C-U2 Intraoral Camera	I MDR	EUDAMED record Report an error
Various dental stomatology instruments - hardware accessories	Z12119080	Implantor LED Micromotors for dental use3 refs	IIa MDR	EUDAMED record Report an error
Various radiodiagnostic and interventional instruments - medical device software	Z11039092	Neowise	IIa MDR	EUDAMED record Report an error

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