Cleared Special

K032904 - ACUCAM CONCEPT IV FWT, MODEL 110-0185G1

K032904 is an FDA 510(k) clearance for ACUCAM CONCEPT IV FWT, manufactured by Dentsply Intl.. The device is a Class 1 Dental device with product code EIA cleared through the Special 510(k) pathway after a 27-day FDA review.

K032904 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
27d
Days
Class 1
Risk

K032904 is an FDA 510(k) clearance for the ACUCAM CONCEPT IV FWT, MODEL 110-0185G1. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Dentsply Intl. (Des Plaines, US). The FDA issued a Cleared decision on October 14, 2003 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dentsply Intl. devices

FDA 510(k) Submission Details - K032904

510(k) Number K032904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2003
Decision Date October 14, 2003
Days to Decision 27 days
Submission Type Special
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
100d faster than avg
Panel avg: 127d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 184
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