Cleared Traditional

K895889 - SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN)

K895889 is an FDA 510(k) clearance for SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN), manufactured by Leach and Dillon Co., Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K895889 · Leach and Dillon Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
181d
Days
Class 2
Risk

K895889 is an FDA 510(k) clearance for the SHAKE N' SPRAY (W/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 4, 1990 after a review of 181 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

FDA 510(k) Submission Details - K895889

510(k) Number K895889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1989
Decision Date April 04, 1990
Days to Decision 181 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
54d slower than avg
Panel avg: 127d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

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 446
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K895889.
PV-CERAMIC, CERAMINIQUE
K901261 · Ivoclar North America, Inc. · Jun 1990
OPAQUE PORCELAIN
K900393 · Dentsply Intl. · Apr 1990
SILHOUETTE PORCELAIN
K895888 · 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
CERESTORE DENTIN PORCELAIN
K850821 · Johnson & Johnson Professionals, Inc. · Apr 1985