Cleared Traditional

K895888 - SILHOUETTE PORCELAIN

K895888 is the FDA 510(k) clearance for SILHOUETTE PORCELAIN by Leach and Dillon Co., Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K895888 · Leach and Dillon Co., Inc. · Dental device
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Apr 1990
Decision
187d
Days
Class 2
Risk

K895888 is an FDA 510(k) clearance for the SILHOUETTE PORCELAIN. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Leach and Dillon Co., Inc. (Mansfield, US). The FDA issued a Cleared decision on April 10, 1990 after a review of 187 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 K895888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1989
Decision Date April 10, 1990
Days to Decision 187 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
60d slower than avg
Panel avg: 127d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 278
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K895888.
DEN-MAT CERINATE PORCELAIN
K895731 · Den-Mat Corp. · Aug 1990
PV-CERAMIC, CERAMINIQUE
K901261 · Ivoclar North America, Inc. · Jun 1990
OPAQUE PORCELAIN
K900393 · Dentsply Intl. · Apr 1990
SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN)
K895889 · Leach and Dillon Co., Inc. · Apr 1990
DICOR CASTABLE CERAMIC-ALL PORCELAIN BRIDGES
K853707 · Dentsply Intl. · Nov 1985
SCOTCHPRIME CERAMIC PRIMER
K853698 · 3M Company · Nov 1985