Cleared Traditional

K984505 - MIRACLE MIX POWDER/LIQUID

K984505 is the FDA 510(k) clearance for MIRACLE MIX POWDER/LIQUID by GC America, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K984505 · GC America, Inc. · Dental device
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Feb 1999
Decision
48d
Days
Class 2
Risk

K984505 is an FDA 510(k) clearance for the MIRACLE MIX POWDER/LIQUID. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on February 4, 1999 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 GC America, Inc. devices

Submission Details

510(k) Number K984505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1998
Decision Date February 04, 1999
Days to Decision 48 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
79d faster than avg
Panel avg: 127d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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.

Regulatory Peers - EMA Cement, Dental

All 254
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K984505.
CARBOCEM ZINC POLYCARBOXYLATE CEMENT
K993324 · Scientific Pharmaceuticals, Inc. · Nov 1999
NEXUS 2
K992160 · Sybron Dental Specialties, Inc. · Aug 1999
TOTALBOND
K990381 · Parkell, Inc. · May 1999
ALUMINA-ZINC OXIDE POWDERS F AND R
K983752 · Harry J. Bosworth Co. · Dec 1998
ZINFOS ZINC PHOSPHATE CEMENT
K982913 · Scientific Pharmaceuticals, Inc. · Oct 1998
TEMPBOND CLEAR-2
K982590 · Sybron Dental Specialties, Inc. · Oct 1998