Cleared Traditional

K892412 - POLYETHER-RETARDER

K892412 is the FDA 510(k) clearance for POLYETHER-RETARDER by Espe GmbH (Us). It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K892412 · Espe GmbH (Us) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
238d
Days
Class 2
Risk

K892412 is an FDA 510(k) clearance for the POLYETHER-RETARDER. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Lake Worth, US). The FDA issued a Cleared decision on December 4, 1989 after a review of 238 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 Espe GmbH (Us) devices

Submission Details

510(k) Number K892412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1989
Decision Date December 04, 1989
Days to Decision 238 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
111d slower than avg
Panel avg: 127d · This submission: 238d
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 167
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K892412.
FORMASIL(R)A POLYVINYL SILOXANE LINE
K901681 · Kulzer, Inc. · Jun 1990
EOS BLUEPHASE-P AND REDPHASE-P IMPRESSION MATERIAL
K896468 · Ivoclar North America, Inc. · Apr 1990
PERMADYNE GARANT LOW VISCOSITY
K896539 · Espe GmbH (Us) · Feb 1990
PALGARAPID
K892839 · Espe GmbH (Us) · Oct 1989
RESOUND IMPRESSION MATERIAL
K892935 · Resound Corp. · Jul 1989
DICOR CERAMIC INLAY - NEW TECHNIC
K884166 · Dentsply Intl. · Apr 1989