Cleared Traditional

K895066 - MONOGRAM IV

K895066 is the FDA 510(k) clearance for MONOGRAM IV by Leach and Dillon Co., Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K895066 · Leach and Dillon Co., Inc. · Dental device
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Feb 1990
Decision
190d
Days
Class 2
Risk

K895066 is an FDA 510(k) clearance for the MONOGRAM IV. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Leach and Dillon Co., Inc. (Mansfield, US). The FDA issued a Cleared decision on February 14, 1990 after a review of 190 days - an extended review 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: 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 Leach and Dillon Co., Inc. devices

Submission Details

510(k) Number K895066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date February 14, 1990
Days to Decision 190 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
63d slower than avg
Panel avg: 127d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 435
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K895066.
DEGUSSA STOPFGOLD (DEGUSSA DIRECT-FILLING GOLD)
K902387 · Degussa AG · Jun 1990
SPARTAN PLUS
K901098 · Ivoclar North America, Inc. · May 1990
GDC 3084 CASTING ALLOY
K901532 · Deringer-Ney, Inc. · May 1990
ARGELITE 80 + 5 DENTAL ALLOY FOR PORCELAIN APPL.
K896348 · Argen Precious Metals, Inc. · Feb 1990
SEQUEL (CASTING ALLOY FOR PORCELAIN-FUSED-METAL)
K893800 · Deringer-Ney, Inc. · Dec 1989
.650 FINE GOLD SOLDER
K895054 · Leach and Dillon Co., Inc. · Dec 1989