Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006610845

FEI Number

3006610845

Entity Name

CEFLA S.C.

City/State/Country

IMOLA Bologna, IT

Establishment Address

VIA BICOCCA 14/C, IMOLA Bologna 40026, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CEFLA S.C. (Owner Number: 9057266)

Owner / Operator Contact Address

Via Bicocca 14/C, Imola, IT-BO 40026, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K151612

PMA Number

N/A

All Registered Proprietary Names

Neowise C-U2 Tethys H10 ZEN-Xi X-VS ZEN-X WDS X-POD X-RADiUS COMPACT hyperion X5 NewTom GO X-RADiUS TRiO PLUS NewTom GiANO HR hyperion X9 pro ZEN-X E X-VS E NewTom DCiS NewTom DCiS WL VENUS PLUS L; VENUS PLUS TML-L; VENUS PLUS CL-L; VENUS PLUS CL-M VENUS PLUS. VENUS PLUS TML WS Aerosol Defender i-MMr L i-XS4 handy POWER LED i-MMr L FLUO i-XR3 i-MMs i-XR3 L FLUO i-XR3 L i-XS4 FLUO i-MMr handy POWER LED FLUO handy POWER implantor LED implantor LED FLUO i-MMs FLUO NewTom 5G XL R1 R7. Stern 300 P NordAm NewTom VGi evo

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-05-07
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2003-08-29
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2021-09-17
LDS	Device, Pasteurization, Hot Water	General Hospital	Class 2	880.6991	2016-11-04
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2010-11-22
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2020-04-16
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2020-04-16
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2023-01-19
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2023-01-19
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2024-11-25
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2022-08-31
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2007-08-29
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2020-05-25
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2024-04-03
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2019-03-14
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-03-14
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2008-02-04
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2016-12-07

Official Correspondent

No official correspondent registered.

US Agent Details

Brett Power Business: Cefla North America Inc Email: brett.power@cefladental.com Phone: (704) 7315249

Related Public Records

Same Entity

CEFLA S.C.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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3030088963	REBRAIN	PESSAC Gironde, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006610845. Last updated year: 2026. Please use registration number 3006610845 when referencing this establishment in official correspondence.