510(k) Report

FDA applicant

Cefla S.C.

Imola (Bo), IT21 decisions2008–20260 recalls

FDA records 21 decisions for Cefla S.C. (Imola (Bo), IT) from 2008 to 2026: 21 510(k) clearances. Most are in product codes OAS (X-Ray, Tomography, Computed, Dental) and FLE (Sterilizer, Steam). Since 2016 its 510(k)s took a median of 60 days from receipt to decision, against 110 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 10 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Cefla S.C.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2008: 12010: 12013: 22015: 22016: 22017: 22019: 22020: 12022: 32023: 12024: 22026 (partial year): 2
2008high 3 (2022) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Cefla S.C. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OASX-Ray, Tomography, Computed, Dental7decisions
  • FLESterilizer, Steam2decisions
  • MUHSystem, X-Ray, Extraoral Source, Digital2decisions
  • EBWController, Foot, Handpiece And Cord2decisions
  • JAKSystem, X-Ray, Tomography, Computed2decisions
  • EIAUnit, Operative Dental2decisions

Also: LQY (1), ELC (1), EHD (1), LLZ (1).

How long do its 510(k) reviews take?

Since 2016, its 13 510(k)s took a median of 60 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 110 days; 8 of its 13 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 10 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123381Hyperion X9Cefla S.C. · 20134cite it
  • K190496hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C. · 20192cite it
  • K151597Family of Steam Sterilizers B 28 seriesCefla S.C. · 20161cites it
  • K200688hyperion X5, NewTom GO, X-RADiUS COMPACTCefla S.C. · 20201cites it
  • K152162Myray- HYPERION X5Cefla S.C. · 20151cites it
  • K213022CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED…Cefla S.C. · 20221cites it

What has FDA decided for it lately?

  • K260716NeowiseCefla S.C. · 2026
  • K252353myray ProXIma X6Cefla S.C. · 2026
  • K230895CEFLA 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…Cefla S.C. · 2024
  • K231990Apex LocatorCefla S.C. · 2024
  • K223794hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C. · 2023
  • K213022CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED…Cefla S.C. · 2022
  • K220664NewTom 7GCefla S.C. · 2022
  • K214084hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C. · 2022

All 21 as Cefla S.C. →

Other applicant names beginning “Cefla”

FDA records each applicant name separately; these may or may not be the same firm.

Cefla S.C.R.L. 3Cefla Dental Group 2Cefla S.C. Cefla Dental Group 1