Cleared Traditional

K895066 - MONOGRAM IV

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

K895066 · Leach and Dillon Co., Inc. · Dental device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K895066

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.

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 551
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