Cleared Traditional

K894924 - 990 GOLD

K894924 is an FDA 510(k) clearance for 990 GOLD, manufactured by Comprehensive Holistic Dentistry. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K894924 · Comprehensive Holistic Dentistry · Dental device
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Oct 1989
Decision
89d
Days
Class 2
Risk

K894924 is an FDA 510(k) clearance for the 990 GOLD. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Comprehensive Holistic Dentistry (Boulder, US). The FDA issued a Cleared decision on October 30, 1989 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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 Comprehensive Holistic Dentistry devices

FDA 510(k) Submission Details - K894924

510(k) Number K894924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1989
Decision Date October 30, 1989
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJT Device Classification - Class 2, Special Controls

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJT Alloy, Gold-based Noble Metal

All 553
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K894924.
MONOGRAM II
K895064 · Leach and Dillon Co., Inc. · Dec 1989
MONOGRAM III
K895065 · Leach and Dillon Co., Inc. · Dec 1989
SELECT 50
K895068 · Leach and Dillon Co., Inc. · Dec 1989
ARGENCO 50 TYPE IV TYPE IV DENTAL GOLD ALLOY
K893566 · Argen Precious Metals, Inc. · Jul 1989
ARGENCO 68 TYPE IV DENTAL GOLD ALLOY
K893565 · Argen Precious Metals, Inc. · Jun 1989
ARGENCO 56 TYPE IV DENTAL GOLD ALLOY
K893568 · Argen Precious Metals, Inc. · Jun 1989