Cleared Traditional

HYDROPHILIC REPROSIL (K863288) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 51
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K863288.
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
NEW LIGHT-CURING IMPRESSION MATERIAL
K862879 · Dentsply Intl. · Sep 1986
POLYJEL N.F. (NEW FORMULA)
K860146 · Dentsply Intl. · Mar 1986
ALGINATE IMPRESSION MATERIAL
K802362 · Dentsply Intl. · Oct 1980