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FDA 510(k)

CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED

K-Number: K213022 · 2022-05-09

ApplicantCefla S.C.
Decision Date2022-05-09
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED is a medical device manufactured by Cefla S.C.. It received FDA 510(k) clearance on 2022-05-09 under approval number K213022. 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-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED?

CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED is a medical device that received FDA 510(k) clearance on 2022-05-09. It is manufactured by Cefla S.C.. The 510(k) number is K213022.

When was CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED approved by the FDA?

CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED received FDA 510(k) clearance on 2022-05-09, under approval number K213022.

What company makes CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED?

CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED is manufactured by Cefla S.C..

What is the FDA product code for CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED?

The FDA product code for CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED is EBW.

Related Clinical Trials

NCT07503314 Comparison of Alignment Efficiency, Arch Dimensional Changes, and Passive Extraction Space Closure Between Self-Ligating and Conventional Brackets COMPLETED

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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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