Cleared Traditional

K041458 - MARE DENTAL OPERATIVE UNIT

K041458 is an FDA 510(k) clearance for MARE DENTAL OPERATIVE UNIT, manufactured by Denimed Electronica S.H.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K041458 · Denimed Electronica S.H. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
84d
Days
Class 1
Risk

K041458 is an FDA 510(k) clearance for the MARE DENTAL OPERATIVE UNIT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Denimed Electronica S.H. (Miami, US). The FDA issued a Cleared decision on August 24, 2004 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K041458

510(k) Number K041458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2004
Decision Date August 24, 2004
Days to Decision 84 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
44d faster than avg
Panel avg: 128d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 277
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K041458.
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K041458 · MARE DENTAL OPERATIVE UNIT
Download PDF FDA Summary Denimed Electronica S…