Medical Device Manufacturer · IT , Imola (Bo)

Cefla S.C.

20 submissions · 20 cleared · Since 2008
20
Total
20
Cleared
0
Denied

Cefla S.C. — FDA 510(k) Submissions

Cefla S.C. has submitted 20 FDA 510(k) premarket notifications since 2008, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include X-ray, Tomography, Computed, Dental, System, X-ray, Tomography, Computed, Controller, Foot, Handpiece And Cord, System, X-ray, Extraoral Source, Digital, Unit, Operative Dental . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
myray ProXIma X6
K252353 · OAS X-ray, Tomography,... · Radiology
Mar 2026 224d
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,
K230895 · EBW Controller, Foot,... · Dental
Apr 2024 367d
Apex Locator
K231990 · LQY Locator, Root Apex · Dental
Feb 2024 223d
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
K223794 · OAS X-ray, Tomography,... · Radiology
Jan 2023 29d
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED
K213022 · EBW Controller, Foot,... · Dental
May 2022 231d
NewTom 7G
K220664 · JAK System, X-ray,... · Radiology
May 2022 60d
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
K214084 · OAS X-ray, Tomography,... · Radiology
Jan 2022 24d
hyperion X5, NewTom GO, X-RADiUS COMPACT
K200688 · OAS X-ray, Tomography,... · Radiology
Apr 2020 24d
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
K190496 · OAS X-ray, Tomography,... · Radiology
Apr 2019 55d
NewTom 5G XL
K183448 · JAK System, X-ray,... · Radiology
Mar 2019 86d
Family of Steam sterilizers B17 B22 Series
K161848 · FLE Sterilizer, Steam · General Hospital
Feb 2017 233d
RX DC
K163519 · EHD Unit, X-ray, Extraoral... · Radiology
Jan 2017 29d
HYPERION X5
K161900 · OAS X-ray, Tomography,... · Radiology
Dec 2016 151d
Family of Steam Sterilizers B 28 series
K151597 · FLE Sterilizer, Steam · General Hospital
Mar 2016 266d
Myray- HYPERION X5
K152162 · MUH System, X-ray, Extraoral... · Radiology
Dec 2015 143d
S200, S300
K133412 · EIA Unit, Operative Dental · Dental
Jan 2015 427d
R7
K130834 · ELC Scaler, Ultrasonic · Dental
Oct 2013 196d
HYPERION X9
K123381 · OAS X-ray, Tomography,... · Radiology
May 2013 190d
STERN'S S250 NORDAM
K092917 · EIA Unit, Operative Dental · Dental
Jun 2010 275d
MYRAY SKYVIEW
K081088 · MUH System, X-ray, Extraoral... · Radiology
Nov 2008 204d
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