Cefla S.C.
IMOLA Bologna, IT
CEFLA S.C. appears in FDA device records in IMOLA Bologna, IT. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Cefla S.C. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Cefla Dental Group510(k), enforcement report, recall
510(k) clearance history
FDA records hold 23 510(k) clearances for Cefla S.C. between 2008 and 2026. The busiest year on record is 2010, with 3. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2010 | 3 |
| 2013 | 2 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 2 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260716 | Neowise | LLZ | Substantially Equivalent | |
| K252353 | myray ProXIma X6 | OAS | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K231990 | Apex Locator | LQY | Substantially Equivalent | |
| K223794 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | OAS | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K220664 | NewTom 7G | JAK | Substantially Equivalent | |
| K214084 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | OAS | Substantially Equivalent | |
| K200688 | hyperion X5, NewTom GO, X-RADiUS COMPACT | OAS | Substantially Equivalent | |
| K190496 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | OAS | Substantially Equivalent | |
| K183448 | NewTom 5G XL | JAK | Substantially Equivalent | |
| K161848 | Family of Steam sterilizers B17 B22 Series | FLE | Substantially Equivalent | |
| K163519 | RX DC | EHD | Substantially Equivalent | |
| K161900 | HYPERION X5 | OAS | Substantially Equivalent | |
| K151597 | Family of Steam Sterilizers B 28 series | FLE | Substantially Equivalent | |
| K152162 | Myray- HYPERION X5 | MUH | Substantially Equivalent | |
| K133412 | S200, S300 | EIA | Substantially Equivalent | |
| K130834 | R7 | ELC | Substantially Equivalent | |
| K123381 | HYPERION X9 | OAS | Substantially Equivalent | |
| K100960 | WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS | MUH | Substantially Equivalent | |
| K101661 | MYRAY HYPERION | MUH | Substantially Equivalent | |
| K092917 | STERN'S S250 NORDAM | EIA | Substantially Equivalent | |
| K081088 | MYRAY SKYVIEW | MUH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006610845 | 3006610845 | CEFLA S.C. | VIA BICOCCA 14/C, IMOLA Bologna 40026 IT | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NRUChair, Dental, Without Operative Unit
- EBWController, Foot, Handpiece And Cord
- LDSDevice, Pasteurization, Hot Water
- EAZLight, Operating, Dental
- LQYLocator, Root Apex
- DYNMouthpiece, Saliva Ejector
- ELCScaler, Ultrasonic
- FLESterilizer, Steam
- LLZSystem, Image Processing, Radiological
- NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- MUHSystem, X-Ray, Extraoral Source, Digital
- JAKSystem, X-Ray, Tomography, Computed
- EIAUnit, Operative Dental
- EHDUnit, X-Ray, Extraoral With Timer
- OASX-Ray, Tomography, Computed, Dental
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1217-2013 | MyRay RXDC dental unit x-ray unit | The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifically, 1. The tube housing did not contain a Certification label. 2. The collimator did not contain an identification label. 3. The user's manual did not contain leakage technique factors, tube housing cooling curves and rating charts, and technique factors which lead to operation at ma | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain