Cleared Traditional

MARE DENTAL OPERATIVE UNIT (K041458) - FDA 510(k) Clearance

Class I Dental device.

K041458 · Denimed Electronica S.H. · Dental device
Download Printable Device Report (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.

View all Denimed Electronica S.H. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 25
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K041458.
Qraypen
K183121 · AIOBIO Co., Ltd. · Jul 2019
Forest Dental Unit
K173608 · Forest Dental Products, Inc. · Aug 2018
P50 Series Dental Operative Unit and Accessories
K171872 · Pelton & Crane · Apr 2018
ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
K032904 · Dentsply Intl. · Oct 2003
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
K000112 · Dentsply Intl. · Apr 2000
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998