Cleared Traditional

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

K213022 is an FDA 510(k) clearance for CEFLA Dental Micromotors: i-MMr, manufactured by Cefla S.C.. The device is a Class 1 Dental device with product code EBW cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K213022 · Cefla S.C. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
231d
Days
Class 1
Risk

K213022 is an FDA 510(k) clearance for the CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy.... Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Cefla S.C. (Imola (Bo), IT). The FDA issued a Cleared decision on May 9, 2022 after a review of 231 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Cefla S.C. devices

FDA 510(k) Submission Details - K213022

510(k) Number K213022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2021
Decision Date May 09, 2022
Days to Decision 231 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 127d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

EBW Device Classification - Class 1, General Controls

Product Code EBW Controller, Foot, Handpiece And Cord
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EBW Controller, Foot, Handpiece And Cord

All 50
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