Cleared Abbreviated

K982692 - STERNOMEGA BONDING AGENT

K982692 is an FDA 510(k) clearance for STERNOMEGA BONDING AGENT, manufactured by Sterngold/Implamed. The device is a Class 2 Dental device with product code EBF cleared through the Abbreviated 510(k) pathway after a 80-day FDA review.

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

FDA 510(k) Submission Details - K982692

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.

EBF Device Classification - Class 2, Special Controls

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 613
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K982692.
ADVENT
K984112 · Bisco, Inc. · Dec 1998
PRODIGY- 3
K983370 · Sybron Dental Specialties, Inc. · Nov 1998
LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
K980800 · Cosmedent, Inc. · Nov 1998
SPECTRUM 800 CURING UNIT
K982318 · Dentsply Intl. · Sep 1998
RENEW
K982729 · Bisco, Inc. · Sep 1998
PYRAMID
K982645 · Bisco, Inc. · Sep 1998