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510(k) 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 by Cefla S.C. — Product Code EBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2022
Date Received
September 20, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Cefla S.C.

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  • K223794 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (January 17, 2023)
  • K220664 — NewTom 7G (May 6, 2022)
  • K214084 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (January 20, 2022)
  • K200688 — hyperion X5, NewTom GO, X-RADiUS COMPACT (April 9, 2020)
  • K190496 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (April 24, 2019)
  • K183448 — NewTom 5G XL (March 8, 2019)
  • K161848 — Family of Steam sterilizers B17 B22 Series (February 23, 2017)

Other clearances for product code EBW

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  • K231562 — ELEC ENGINE (Model: ISE-170L) (July 18, 2025)
  • K242646 — Dental Implant Unit (April 11, 2025)
  • K233288 — NLZ Built-In Motor System (June 24, 2024)
  • K233117 — Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) (June 20, 2024)
  • K230895 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3 (April 1, 2024)
  • K231864 — Fiber Optic Brushless Electronic Micromotor, model: iM100 (March 11, 2024)
  • K211358 — Implanter incl. Accessories (November 21, 2022)