Cleared Traditional

K863288 - HYDROPHILIC REPROSIL

K863288 is an FDA 510(k) clearance for HYDROPHILIC REPROSIL, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K863288 · Dentsply Intl. · Dental device
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Dec 1986
Decision
98d
Days
Class 2
Risk

K863288 is an FDA 510(k) clearance for the HYDROPHILIC REPROSIL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on December 1, 1986 after a review of 98 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K863288

510(k) Number K863288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1986
Decision Date December 01, 1986
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
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 322
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K863288.
OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL
K881091 · Coe Laboratories, Inc. · Jun 1988
VINYL POLYSILOXANE IMPRESSION SYSTEM
K872745 · Crown Delta Corp. · Jul 1987
VINYL POLYSILOXANE IMPRESSION SYSTEM
K871409 · Crown Delta Corp. · Jun 1987
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