Cleared Traditional

K860855 - SHUR GEL 4

K860855 is an FDA 510(k) clearance for SHUR GEL 4, manufactured by Columbus Dental Mfg. Co.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K860855 · Columbus Dental Mfg. Co. · Dental device
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Jun 1986
Decision
101d
Days
Class 2
Risk

K860855 is an FDA 510(k) clearance for the SHUR GEL 4. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Columbus Dental Mfg. Co. (St. Louis, US). The FDA issued a Cleared decision on June 16, 1986 after a review of 101 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 Columbus Dental Mfg. Co. devices

FDA 510(k) Submission Details - K860855

510(k) Number K860855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1986
Decision Date June 16, 1986
Days to Decision 101 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 128d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

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 332
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K860855.
VINYL POLYSILOXANE IMPRESSION SYSTEM
K871409 · Crown Delta Corp. · Jun 1987
HYDROPHILIC REPROSIL
K863288 · Dentsply Intl. · Dec 1986
NEW LIGHT-CURING IMPRESSION MATERIAL
K862879 · Dentsply Intl. · Sep 1986
AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL
K860911 · Austenal Dental, Inc. · Mar 1986
KERR POL-E-LASTIC DENTAL IMPRESSION MATERIAL
K860532 · Kerr Corporation (Danbury) · Mar 1986
IMPREGUM-F
K853529 · Espe GmbH (Us) · Mar 1986