Cleared Traditional

MERCURY DENTAL (K973548) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K973548 · Aleaciones Dentales Zeyco, S.A. DE C.V. · Dental device
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Mar 1998
Decision
186d
Days
Class 2
Risk

K973548 is an FDA 510(k) clearance for the MERCURY DENTAL. Classified as Mercury (product code ELY), Class II - Special Controls.

Submitted by Aleaciones Dentales Zeyco, S.A. DE C.V. (Guadalajara, MX). The FDA issued a Cleared decision on March 23, 1998 after a review of 186 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3070 - 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 Aleaciones Dentales Zeyco, S.A. DE C.V. devices

Submission Details

510(k) Number K973548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1997
Decision Date March 23, 1998
Days to Decision 186 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 127d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELY Mercury
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.