Cleared Traditional

K973548 - MERCURY DENTAL

K973548 is an FDA 510(k) clearance for MERCURY DENTAL, manufactured by Aleaciones Dentales Zeyco, S.A. DE C.V.. The device is a Class 2 Dental device with product code ELY cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K973548 · Aleaciones Dentales Zeyco, S.A. DE C.V. · Dental device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K973548

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
Combination Product No
PCCP Authorized No
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.

ELY Device Classification - Class 2, Special Controls

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.