Dental Device Guide
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Manufacturer registered with FDA

Cefla S.C.

Imola, Italy. Lists 10 dental device types with FDA across 1 registered establishment, and holds 15 510(k) clearances as applicant.

FDA owner/operator9057266ManufacturerRepacker / relabeler5 clearances in five years
Device types listed
10
Brands and models
84
510(k) clearances
152008–2026
Markets registered in
18566 registrations outside the US
Establishments
1Italy
2008: 12010: 12013: 22015: 22016: 12017: 12019: 12020: 12022: 22023: 12024: 12026: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 18 markets

Where regulators' registries name Cefla S.C. as the manufacturer or the registration holder of a device.

All markets
United States: 10 device types listedCanada: 169 registrationsSaudi Arabia: 144 registrationsTaiwan: 50 registrationsAustralia: 35 registrationsSerbia: 31 registrationsEuropean Union: 30 registrationsCosta Rica: 29 registrationsChina: 20 registrationsPeru: 17 registrationsUnited Kingdom: 16 registrationsIsrael: 11 registrationsColombia: 4 registrationsBrazil: 3 registrationsHong Kong: 2 registrationsPhilippines: 2 registrationsSouth Korea: 2 registrationsJapan: 1 registrations
RegisteredHome: ItalyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerCefla S.C.15 clearances2008–2026Below
CanadaHealth CanadaRegistration holderCEFLA S.C.1692004–2025Pure Global AI
Saudi ArabiaSFDAManufacturerCEFLA s.c.CEFLA S.C.144—Pure Global AI
TaiwanTFDAManufacturerCefla S.C.CEFLA S.C. · Cefla s.c. · +1502008–2026Pure Global AI
AustraliaTGAManufacturerCefla SC352007–2026Pure Global AI
SerbiaALIMSManufacturerCEFLA S.C.312024–2025Pure Global AI
European UnionEUDAMEDManufacturerCEFLA s.c.30—Pure Global AI
Costa RicaMinisterio de SaludManufacturerCEFLA s.c.Cefla S.C. · CEFLA S.C.29—Pure Global AI
ChinaNMPARegistration holder赛福徕集团CEFLA S.C.赛福徕集团 CEFLA S.C.20—Pure Global AI
PeruDIGEMIDManufacturerCEFLA S.C.CEFLA s.c.172019–2026Pure Global AI
United KingdomMHRAManufacturerCefla s.c.16—Pure Global AI
IsraelAMARManufacturerCefla s.cCefla S.C. · Cefla s.c. · +111—Pure Global AI
ColombiaINVIMARegistration holderCEFLA S.C.4—Pure Global AI
BrazilANVISAManufacturerCEFLA S.C.32021–2022Pure Global AI
Hong KongMDDManufacturerCEFLA S.C.22025–2026Pure Global AI
PhilippinesFDA PhilippinesManufacturerCEFLA, S.C.22025–2025Pure Global AI
South KoreaMFDSManufacturerCefla s.c.22017–2018Pure Global AI
JapanPMDARegistration holderＣＥＦＬＡ　ｓ．　ｃ．12020–2020Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Cefla S.C. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Digital Extraoral Source X-Ray SystemMUH · Class 2Dental X-ray unitsMaker
EOS Compacthyperion X5hyperion X9 proNewTom DCiSNewTom DCiS WLNewTom GiANO HRNewTom GONewTom VG-OneProXIma X6WDS X-POD
7 more
X-RADiUS COMPACTX-RADiUS TRiO PLUSX-VSX-VS EZEN-XZEN-X EZEN-Xi
2010
Dental Computed Tomography X-RayOAS · Class 2Dental CBCTMaker
EOS Compacthyperion X5hyperion X9 proNewTom 5G XLNewTom 7GNewTom GiANO HRNewTom GONewTom VG-OneNewTom VGi evoProXIma X6
2 more
X-RADiUS COMPACTX-RADiUS TRiO PLUS
2016
Operative Dental UnitEIA · Class 1Dental chairs & operative unitsMaker
C-U2PUMA ELI A R M CART; PUMA ELI A R ORTHO; DAMA AMBIDXPUMA ELI A R; PUMA ELI A R CP; PUMA ELI A R CART; PUMA ELI A R M; PUMA ELI A R M CPR7R7 CARTR7 CONTINENTALR7 INTERNATIONALR7 M CARTR7 M CONTINENTALR7 M INTERNATIONAL
2 more
R7 ORTHOR7 P
2003
Saliva Ejector MouthpieceDYN · Class 1—Maker
WS Aerosol Defender
2020
Dental Operating LightEAZ · Class 1Dental operating lightsMaker
VENUS PLUS CL MCT; VENUS PLUS CL SCT; VENUS PLUS CL SCT COMPOSITE; VENUS PLUSCL MCT VIEWVENUS PLUS E-Led; VENUS PLUS SCT; VENUS PLUS SCT COMPOSITE; VENUS PLUS MCT VIEWVENUS PLUS L; VENUS PLUS TML-L; VENUS PLUS CL-L; VENUS PLUS CL-MVENUS PLUS WM SCT; VENUS PLUS WM SCT COMPOSITE; VENUS PLUS WM MCT; VENUS PLUS WM MCT VIEWVENUS PLUS. VENUS PLUS TML
2007
Handpiece and Cord Foot ControllerEBW · Class 1—Maker
handy POWERhandy POWER LEDhandy POWER LED FLUOi-MMri-MMr Li-MMr L FLUOi-MMsi-MMs FLUOi-XR3i-XR3 L
5 more
i-XR3 L FLUOi-XS4i-XS4 FLUOimplantor LEDimplantor LED FLUO
2024
Extraoral with Timer X-Ray UnitEHD · Class 2Dental X-ray unitsMaker
RX DC
2017
Ultrasonic ScalerELC · Class 2Ultrasonic scalersMaker
PUMA ELI A R M CART; PUMA ELI A R ORTHO; DAMA AMBIDXPUMA ELI A R; PUMA ELI A R CP; PUMA ELI A R CART; PUMA ELI A R M; PUMA ELI A R M CPR7R7 CARTR7 CONTINENTALR7 INTERNATIONALR7 M CARTR7 M CONTINENTALR7 M INTERNATIONALR7 ORTHO
1 more
R7 P
2013
Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2Intraoral scannersLister
AlphaScan WLAlphaScan WRMyScan WLMyScan WRNewTom IOSVisioScan WLVisioScan WR
2011
Dental Chair without Operative UnitNRU · Class 1Dental chairs & operative unitsMaker
R1R7.Stern 300 P NordAm
2008

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Cefla S.C. as the applicant.

Decided510(k)DeviceDevice type
10 Mar 2026K252353myray ProXIma X6OAS Dental Computed Tomography X-Ray
1 Apr 2024K230895CEFLA 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 Handpiece and Cord Foot Controller
17 Jan 2023K223794hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS Dental Computed Tomography X-Ray
9 May 2022K213022CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LEDEBW Handpiece and Cord Foot Controller
20 Jan 2022K214084hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS Dental Computed Tomography X-Ray
9 Apr 2020K200688hyperion X5, NewTom GO, X-RADiUS COMPACTOAS Dental Computed Tomography X-Ray
24 Apr 2019K190496hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS Dental Computed Tomography X-Ray
13 Jan 2017K163519RX DCEHD Extraoral with Timer X-Ray Unit
9 Dec 2016K161900HYPERION X5OAS Dental Computed Tomography X-Ray
24 Dec 2015K152162Myray- HYPERION X5MUH Digital Extraoral Source X-Ray System
8 Jan 2015K133412S200, S300EIA Operative Dental Unit
8 Oct 2013K130834R7ELC Ultrasonic Scaler
10 May 2013K123381HYPERION X9OAS Dental Computed Tomography X-Ray
24 Jun 2010K092917STERN'S S250 NORDAMEIA Operative Dental Unit
6 Nov 2008K081088MYRAY SKYVIEWMUH Digital Extraoral Source X-Ray System

Also lists devices cleared under other names

Cefla S.C. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Athlos Oy (1), Iray Technology Taicang , Ltd. (1), Qr S.R.L. (1), Cefla Dental Group (1), Cefla S.C.R.L. (1).

Decided510(k)DeviceApplicantDevice type
22 Jul 2021K211688DC-Air and Athlos-1 and Athlos-AirAthlos OyMUH Digital Extraoral Source X-Ray System
23 Apr 2021K210312PlutoX Digital Intraoral X-Ray Imaging SystemIray Technology Taicang , Ltd.MUH Digital Extraoral Source X-Ray System
31 Mar 2016K151612NewTom VGi evoQr S.R.L.OAS Dental Computed Tomography X-Ray
21 Oct 2010K100960WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORSCefla Dental GroupMUH Digital Extraoral Source X-Ray System
14 Dec 2006K062897C-U2Cefla S.C.R.L.EIA Operative Dental Unit

Registered establishments

EstablishmentLocationWhat it does
CEFLA S.C.FDA reg. 3006610845IMOLA Bologna, ItalyManufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9057266). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.