Cleared Traditional

K033419 - STV PRO 2

K033419 is an FDA 510(k) clearance for STV PRO 2, manufactured by Trophy Radiologie. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K033419 · Trophy Radiologie · Dental device
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Feb 2004
Decision
98d
Days
Class 1
Risk

K033419 is an FDA 510(k) clearance for the STV PRO 2. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Trophy Radiologie (Marne La Vallee Cedex 2, FR). The FDA issued a Cleared decision on February 2, 2004 after a review of 98 days - within the typical 510(k) review window.

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: 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 Trophy Radiologie devices

FDA 510(k) Submission Details - K033419

510(k) Number K033419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2003
Decision Date February 02, 2004
Days to Decision 98 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 127d · This submission: 98d
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

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