Cleared Abbreviated

STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC (K982692) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K982692 · Sterngold/Implamed · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
80d
Days
Class 2
Risk

K982692 is an FDA 510(k) clearance for the STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Sterngold/Implamed (Pawtucket, US). The FDA issued a Cleared decision on October 22, 1998 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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

Submission Details

510(k) Number K982692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1998
Decision Date October 22, 1998
Days to Decision 80 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
47d faster than avg
Panel avg: 127d · This submission: 80d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 195
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K982692.
3M ESPE HAUR
K010781 · 3M Company · Apr 2001
3M LVR SYSTEM
K991961 · 3M Company · Aug 1999
R-30 AESTHETIC RESTORATIVE
K984387 · Dentsply Intl. · Jan 1999
SPECTRUM 800 CURING UNIT
K982318 · Dentsply Intl. · Sep 1998
DYTRACT FLOW RESTORATIVE
K982395 · Dentsply Intl. · Aug 1998
3M DENT II SYSTEM
K981647 · 3M Company · Aug 1998