Cleared Traditional

K895798 - SILCOT COPAL CAVITY VARNISH

K895798 is the FDA 510(k) clearance for SILCOT COPAL CAVITY VARNISH by Specialites Septodont. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K895798 · Specialites Septodont · Dental device
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Dec 1989
Decision
84d
Days
Class 2
Risk

K895798 is an FDA 510(k) clearance for the SILCOT COPAL CAVITY VARNISH. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on December 21, 1989 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Specialites Septodont devices

Submission Details

510(k) Number K895798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1989
Decision Date December 21, 1989
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 287
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K895798.
GRANITEC Z2, ZINC PHOSPHATE CEMENT
K896649 · Confi-Dental Products Co. · Feb 1990
GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS
K894953 · Confi-Dental Products Co. · Feb 1990
BANDTITE GLASS IONOMER CEMENT
K896249 · American Orthodontics · Jan 1990
KULZER GLAS-IONOMER CEMENT
K892453 · Kulzer, Inc. · Dec 1989
TEMP BOND NE
K894219 · Kerr Corporation (Danbury) · Sep 1989
CHELON-FIL
K884475 · Espe GmbH (Us) · Dec 1988