Cleared Abbreviated

K984340 - STERNOMEGA TEMPORARY CEMENT AUTOMIX NE

K984340 is an FDA 510(k) clearance for STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, manufactured by Sterngold/Implamed. The device is a Class 2 Dental device with product code EMA cleared through the Abbreviated 510(k) pathway after a 35-day FDA review.

K984340 · Sterngold/Implamed · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
35d
Days
Class 2
Risk

K984340 is an FDA 510(k) clearance for the STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Sterngold/Implamed (Attleboro, US). The FDA issued a Cleared decision on January 8, 1999 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sterngold/Implamed devices

FDA 510(k) Submission Details - K984340

510(k) Number K984340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1998
Decision Date January 08, 1999
Days to Decision 35 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 127d · This submission: 35d
Pathway characteristics
Standards-based clearance path.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 300
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K984340.
TOTALBOND
K990381 · Parkell, Inc. · May 1999
MIRACLE MIX POWDER/LIQUID
K984505 · GC America, Inc. · Feb 1999
PROCEM
K984248 · Espe Dental AG · Jan 1999
ALUMINA-ZINC OXIDE POWDERS F AND R
K983752 · Harry J. Bosworth Co. · Dec 1998
ZINFOS ZINC PHOSPHATE CEMENT
K982913 · Scientific Pharmaceuticals, Inc. · Oct 1998
TEMPBOND CLEAR-2
K982590 · Sybron Dental Specialties, Inc. · Oct 1998