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FDA 510(k)

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,

K-Number: K230895 · 2024-04-01

ApplicantCefla S.C.
Decision Date2024-04-01
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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, is a medical device manufactured by Cefla S.C.. It received FDA 510(k) clearance on 2024-04-01 under approval number K230895. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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,?

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, is a medical device that received FDA 510(k) clearance on 2024-04-01. It is manufactured by Cefla S.C.. The 510(k) number is K230895.

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, approved 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, received FDA 510(k) clearance on 2024-04-01, under approval number K230895.

What company makes 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,?

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, is manufactured by Cefla S.C..

What is the FDA product code for 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,?

The FDA product code for 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, is EBW.

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Related Devices (Code: EBW)

K161957W&H Implantmed SI-1015 incl. AccessoriesW&H Dentalwerk Burmoos GmbH K163402NLZ Motor SystemNakanishi, Inc. K163131A-dec NLZ Electric Motor SystemNakanishi, Inc. K163317ELECTROmaticKaltenbach & Voigt Gmgh K161213XSmart iQDentsply Sirona K173905Surgic Pro, Surgic Pro+Nakanishi, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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