Data / Medical devices / Italy / Cefla S.C.

Cefla S.C.: FDA-registered device maker in IMOLA Bologna, Italy, 15 510(k) clearances

Name: Cefla S.C. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cefla S.C. is registered with the FDA (registration 3006610845) in IMOLA Bologna, Italy. It lists 15 device types. The FDA files 15 510(k) clearances under its listings, the newest dated May 4, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Cefla S.C.

FDA registration number: 3006610845
Address: Via Bicocca 14/C, IMOLA Bologna, Italy, 40026
Owner or operator: CEFLA S.C. (9057266)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: August 29, 2003
Registered through: 2027
Brand names listed: AlphaScan WL, AlphaScan WR, Apex Locator, C-U2, EOS Compact, MyScan WL, MyScan WR, Neowise and more

Devices it lists

Device	Product code	Class	Role	Source
Chair, Dental, Without Operative Unit	NRU	1	Manufacturer	accessdata.fda.gov
Controller, Foot, Handpiece And Cord	EBW	1	Manufacturer	accessdata.fda.gov
Device, Pasteurization, Hot Water	LDS	2	Manufacturer	accessdata.fda.gov
Light, Operating, Dental	EAZ	1	Manufacturer	accessdata.fda.gov
Locator, Root Apex	LQY	U	Manufacturer	accessdata.fda.gov
Mouthpiece, Saliva Ejector	DYN	1	Manufacturer	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Manufacturer	accessdata.fda.gov
Sterilizer, Steam	FLE	2	Contract manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Manufacturer	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Manufacturer	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Manufacturer	accessdata.fda.gov
X-Ray, Tomography, Computed, Dental	OAS	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 4, 2026	K260716	Neowise	LLZ	Substantially Equivalent	Cefla S.C.	accessdata.fda.gov
March 10, 2026	K252353	myray ProXIma X6	OAS	Substantially Equivalent	Cefla S.C.	accessdata.fda.gov
April 1, 2024	K230895	CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,	EBW	Substantially Equivalent	Cefla S.C.	accessdata.fda.gov
February 13, 2024	K231990	Apex Locator	LQY	Substantially Equivalent	Cefla S.C.	accessdata.fda.gov
January 17, 2023	K223794	hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS	OAS	Substantially Equivalent	Cefla S.C.	accessdata.fda.gov
May 6, 2022	K220664	NewTom 7G	JAK	Substantially Equivalent	Cefla S.C.	accessdata.fda.gov
July 22, 2021	K211688	DC-Air and Athlos-1 and Athlos-Air	MUH	Substantially Equivalent	Athlos OY	accessdata.fda.gov
April 23, 2021	K210312	PlutoX Digital Intraoral X-Ray Imaging System	MUH	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
April 9, 2020	K200688	hyperion X5, NewTom GO, X-RADiUS COMPACT	OAS	Substantially Equivalent	Cefla S.C.	accessdata.fda.gov
March 8, 2019	K183448	NewTom 5G XL	JAK	Substantially Equivalent	Cefla S.C.	accessdata.fda.gov
January 13, 2017	K163519	RX DC	EHD	Substantially Equivalent	Cefla S.C.	accessdata.fda.gov
March 31, 2016	K151612	NewTom VGi evo	OAS	Substantially Equivalent	Qr S.R.L.	accessdata.fda.gov
October 8, 2013	K130834	R7	ELC	Substantially Equivalent	Cefla S.C.	accessdata.fda.gov
October 21, 2010	K100960	WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS	MUH	Substantially Equivalent	Cefla Dental Group	accessdata.fda.gov
December 14, 2006	K062897	C-U2	EIA	Substantially Equivalent	Cefla S.C.R.L.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 10, 2012	65036	Class II	Terminated	MyRay RXDC dental unit x-ray unit	The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifically, 1. The tube housing did not contain a Certification label. 2. The collimator did not contain an identification label. 3. The user's manual did not contain leakage technique factors, tube housing cooling curves and rating charts, and technique fa	accessdata.fda.gov

Compare with other makers

Updated May 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.