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,
FDA 510(k) K230895 · Cefla S.C.
510(k) numberK230895
Submission
- Device name
- 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,
- Applicant
- Cefla S.C.
Imola, IT - Received
- March 31, 2023
- Decision date
- April 1, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K233288 | NLZ Built-In Motor SystemEBW · Traditional | Nakanishi, Inc. | 06/24/2024SE |
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| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100EBW · Traditional | Codent Technical Industry Co., Ltd. | 03/11/2024SE |
| K211358 | Implanter incl. AccessoriesEBW · Traditional | Guilin Woodpecker Medical Instrument Co., Ltd. | 11/21/2022SE |
| K220831 | Dental Implantation Systems, Dental Electrical MotorsEBW · Traditional | Foshan Coxo Medical Instrument Co., Ltd. | 09/27/2022SE |
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| K223794 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS · Special | 01/17/2023SE |
| K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER…EBW · Traditional | 05/09/2022SE |
| K220664 | NewTom 7GJAK · Traditional | 05/06/2022SE |
| K214084 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS · Special | 01/20/2022SE |
| K200688 | hyperion X5, NewTom GO, X-RADiUS COMPACTOAS · Traditional | 04/09/2020SE |
| K190496 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS · Traditional | 04/24/2019SE |
| K183448 | NewTom 5G XLJAK · Traditional | 03/08/2019SE |
Questions and answers
When was 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, cleared by the FDA?
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, (K230895) received a 510(k) decision of Substantially Equivalent on April 1, 2024, 367 days after the submission was received.
What is the product code of K230895?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.