# Cefla S.C.

- Location (FDA's records): Imola (Bo), IT
- FDA decisions: 21 (2008–2026): 21 510(k) clearances
- Product codes: OAS (7), FLE (2), MUH (2), EBW (2), JAK (2), EIA (2), LQY (1), ELC (1), EHD (1), LLZ (1)
- 510(k) review time since 2016: median 60 days, against 110 for FDA's reviews in the same codes and years (8 of 13 faster)
- Predicates its devices cite: 17 (10 its own); citations of its devices by later devices: 14 (10 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Guilin Woodpecker Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/guilin-woodpecker-medical-instrument)
- M.O. Com S.R.L.: 1 (https://510kreport.com/company/mo-com)
- Tuttnauer U.S.A Co, Ltd.: 1 (https://510kreport.com/company/tuttnauer-usa)
- W&H Dentalwerk Buermoos GmbH: 1 (https://510kreport.com/company/w-h-dentalwerk-buermoos)
- Cefla S.C.R.L.: 1 (https://510kreport.com/company/cefla-scrl)
- Vivi S.R.L.: 1 (https://510kreport.com/company/vivi)
- Planmeca Oy: 1 (https://510kreport.com/company/planmeca)

## Firms that cite its devices most
- Planmed OY: 1 (https://510kreport.com/company/planmed)
- Trident S.R.L: 1 (https://510kreport.com/company/trident)
- Genoray Co., Ltd.: 1 (https://510kreport.com/company/genoray)
- De Gotzen S.R.L.: 1 (https://510kreport.com/company/de-gotzen)

## Its most-cited devices
- K123381: Hyperion X9 (2013), cited by 4
- K190496: hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (2019), cited by 2
- K151597: Family of Steam Sterilizers B 28 series (2016), cited by 1
- K200688: hyperion X5, NewTom GO, X-RADiUS COMPACT (2020), cited by 1
- K152162: Myray- HYPERION X5 (2015), cited by 1
- 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 (2022), cited by 1

## Recent decisions
- K260716: Neowise (May 4, 2026)
- K252353: myray ProXIma X6 (Mar 10, 2026)
- 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, (Apr 1, 2024)
- K231990: Apex Locator (Feb 13, 2024)
- K223794: hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (Jan 17, 2023)
- 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 (May 9, 2022)
- K220664: NewTom 7G (May 6, 2022)
- K214084: hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (Jan 20, 2022)

Source page: https://510kreport.com/company/cefla-sc