Cleared Traditional

K884166 - DICOR CERAMIC INLAY - NEW TECHNIC

K884166 is an FDA 510(k) clearance for DICOR CERAMIC INLAY - NEW TECHNIC, 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 195-day FDA review.

K884166 · Dentsply Intl. · Dental device
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Apr 1989
Decision
195d
Days
Class 2
Risk

K884166 is an FDA 510(k) clearance for the DICOR CERAMIC INLAY - NEW TECHNIC. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on April 17, 1989 after a review of 195 days - an extended review cycle.

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 - K884166

510(k) Number K884166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1988
Decision Date April 17, 1989
Days to Decision 195 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
68d slower than avg
Panel avg: 127d · This submission: 195d
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 K884166.
PALGARAPID
K892839 · Espe GmbH (Us) · Oct 1989
FIRST IMPRESSION WITH CHLORHEXIDINE
K894281 · Coe Laboratories, Inc. · Sep 1989
RESOUND IMPRESSION MATERIAL
K892935 · Resound Corp. · Jul 1989
DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.
K883842 · Dentsply Intl. · Mar 1989
PALGAFLEX AND PALGAFLEX-QUICK
K884381 · Espe GmbH (Us) · Jan 1989
IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL
K882690 · 3M Company · Aug 1988