Cefla S.C.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Cefla S.C.” (first 2008, latest 2026), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 190 days. Since 2017 the median was 60 days, against 126 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 193 |
| 2014 | 0 | — |
| 2015 | 2 | 285 |
| 2016 | 2 | 208 |
| 2017 | 2 | 131 |
| 2018 | 0 | — |
| 2019 | 2 | 70 |
| 2020 | 1 | 24 |
| 2021 | 0 | — |
| 2022 | 3 | 60 |
| 2023 | 1 | 29 |
| 2024 | 2 | 295 |
| 2025 | 0 | — |
| 2026 | 2 | 142 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cefla S.C. took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | 7 | 7 |
| EBW | Controller, Foot, Handpiece And Cord | 2 | 2 |
| EIA | Unit, Operative Dental | 2 | 2 |
| FLE | Sterilizer, Steam | 2 | 2 |
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
| MUH | System, X-Ray, Extraoral Source, Digital | 2 | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| ELC | Scaler, Ultrasonic | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| LQY | Locator, Root Apex | 1 | 1 |
Review panels
- Radiology (13)
- Dental (6)
- General Hospital (2)
Most recent Cefla S.C. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260716 | Neowise | LLZ | 2026-05-04 | 60 |
| K252353 | myray ProXIma X6 | OAS | 2026-03-10 | 224 |
| 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 | 2024-04-01 | 367 |
| K231990 | Apex Locator | LQY | 2024-02-13 | 223 |
| K223794 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | OAS | 2023-01-17 | 29 |
| 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 | 2022-05-09 | 231 |
| K220664 | NewTom 7G | JAK | 2022-05-06 | 60 |
| K214084 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | OAS | 2022-01-20 | 24 |
| K200688 | hyperion X5, NewTom GO, X-RADiUS COMPACT | OAS | 2020-04-09 | 24 |
| K190496 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | OAS | 2019-04-24 | 55 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cefla S.C..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cefla S.C.R.L. (3 510(k)s)
- Cefla Dental Group (2 510(k)s)
- Cefla S.C. Cefla Dental Group (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cefla S.C.?
FDA lists 21 510(k) clearances under the applicant name “Cefla S.C.” (first 2008, latest 2026), across 10 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cefla S.C.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cefla S.C. is 190 days. Since 2017: 60 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cefla S.C.?
The most frequent FDA product codes under this applicant name are OAS (X-Ray, Tomography, Computed, Dental, 7); EBW (Controller, Foot, Handpiece And Cord, 2); EIA (Unit, Operative Dental, 2).
Next steps
- See all 21 Cefla S.C. clearances with predicates and recalls
- Run predicate analysis for product code OAS, Cefla S.C.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.