Cleared Traditional

K230895 - CEFLA Dental Micromotors: i-MMr

Also marketed or referenced as:
i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,

K230895 is the FDA 510(k) clearance for CEFLA Dental Micromotors: i-MMr by Cefla S.C.. It is a Class 1 Dental device (product code EBW) cleared through the Traditional 510(k) pathway after a 367-day FDA review.

K230895 · Cefla S.C. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
367d
Days
Class 1
Risk

K230895 is an FDA 510(k) clearance for the CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Cefla S.C. (Imola, IT). The FDA issued a Cleared decision on April 1, 2024 after a review of 367 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K230895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2023
Decision Date April 01, 2024
Days to Decision 367 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
240d slower than avg
Panel avg: 127d · This submission: 367d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 30
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K230895.
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