Chrysalis Intelligence · Sponsors · Cefla S.C.

Cefla S.C.

Imola, IT · 9 510(k) clearances

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Total clearances
9
2020-04-09 → 2026-05-04
Last 12 months
2
Product codes
5
Most recent
2026-05-04
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OAS X-Ray, Tomography, Computed, Dental Class II Radiology 4 2026-03-10
EBW Controller, Foot, Handpiece And Cord Class I Dental 2 2024-04-01
LLZ System, Image Processing, Radiological Class II Radiology 1 2026-05-04
LQY — — — 1 2024-02-13
JAK System, X-Ray, Tomography, Computed Class II Radiology 1 2022-05-06
Filings

All 510(k) clearances (9)

Date K-number Device Code Class Specialty
2026-05-04 K260716 Neowise LLZ Class II Radiology
2026-03-10 K252353 myray ProXIma X6 OAS Class II Radiology
2024-04-01 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 Class I Dental
2024-02-13 K231990 Apex Locator LQY — —
2023-01-17 K223794 hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS OAS Class II Radiology
2022-05-09 K213022 CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED EBW Class I Dental
2022-05-06 K220664 NewTom 7G JAK Class II Radiology
2022-01-20 K214084 hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS OAS Class II Radiology
2020-04-09 K200688 hyperion X5, NewTom GO, X-RADiUS COMPACT OAS Class II Radiology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence