Cleared Traditional

K902388 - DENTAL-QUECKSILBER (DENTAL MERCURY)

K902388 is the FDA 510(k) clearance for DENTAL-QUECKSILBER (DENTAL MERCURY) by Degussa AG. It is a Class 2 Dental device (product code ELY) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K902388 · Degussa AG · Dental device
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Jun 1990
Decision
29d
Days
Class 2
Risk

K902388 is an FDA 510(k) clearance for the DENTAL-QUECKSILBER (DENTAL MERCURY). Classified as Mercury (product code ELY), Class II - Special Controls.

Submitted by Degussa AG (West Germany, DE). The FDA issued a Cleared decision on June 28, 1990 after a review of 29 days - a notably fast clearance 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: 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 Degussa AG devices

Submission Details

510(k) Number K902388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1990
Decision Date June 28, 1990
Days to Decision 29 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 127d · This submission: 29d
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.