Cleared Traditional

K984341 - STERNVANTAGE VARNISH LC, MODEL 221001

K984341 is an FDA 510(k) clearance for STERNVANTAGE VARNISH LC, manufactured by Sterngold/Implamed. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K984341 · Sterngold/Implamed · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
35d
Days
Class 2
Risk

K984341 is an FDA 510(k) clearance for the STERNVANTAGE VARNISH LC, MODEL 221001. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), 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 872.3760 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sterngold/Implamed devices

FDA 510(k) Submission Details - K984341

510(k) Number K984341 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 Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 127d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 261
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K984341.
FUSICRYL
K984467 · Micro Dental Laboratories · Feb 1999
A-SOFT RELINER
K984483 · S & C Polymer GmbH · Feb 1999
RESIN 4
K981862 · Harry J. Bosworth Co. · Feb 1999
PROTECH PLUS
K983547 · Protech, Inc. · Jan 1999
MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC
K983876 · Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind · Dec 1998
MUCOPREN SOFT RELINING SYSTEM
K983357 · Roydent Dental Products, Inc. · Nov 1998