Cleared Traditional

OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL (K881091) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881091 · Coe Laboratories, Inc. · Dental device
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Jun 1988
Decision
112d
Days
Class 2
Risk

K881091 is an FDA 510(k) clearance for the OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Coe Laboratories, Inc. (Alsip, US). The FDA issued a Cleared decision on June 28, 1988 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Coe Laboratories, Inc. devices

Submission Details

510(k) Number K881091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1988
Decision Date June 28, 1988
Days to Decision 112 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 127d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 52
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K881091.
DICOR CERAMIC INLAY - NEW TECHNIC
K884166 · Dentsply Intl. · Apr 1989
DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.
K883842 · Dentsply Intl. · Mar 1989
IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL
K882690 · 3M Company · Aug 1988
HYDROPHILIC REPROSIL
K863288 · Dentsply Intl. · Dec 1986
NEW LIGHT-CURING IMPRESSION MATERIAL
K862879 · Dentsply Intl. · Sep 1986
POLYJEL N.F. (NEW FORMULA)
K860146 · Dentsply Intl. · Mar 1986