Cleared Traditional

K980963 - HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)

K980963 is an FDA 510(k) clearance for HONIGUM AUTOMIX IMPRESSION MATERIAL (FO..., manufactured by Foremost Dental Mfg., Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K980963 · Foremost Dental Mfg., Inc. · Dental device
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May 1998
Decision
56d
Days
Class 2
Risk

K980963 is an FDA 510(k) clearance for the HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION .... Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Foremost Dental Mfg., Inc. (Chicago, US). The FDA issued a Cleared decision on May 11, 1998 after a review of 56 days - a notably fast clearance 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: 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 Foremost Dental Mfg., Inc. devices

FDA 510(k) Submission Details - K980963

510(k) Number K980963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1998
Decision Date May 11, 1998
Days to Decision 56 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

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 319
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K980963.
3M M.G. MATERIAL
K981325 · 3M Company · Jun 1998
LONE STAR IMPRESSION SYSTEMS
K980968 · Lone Star Technologies · Jun 1998
NEOCOLLOID, ORTHOPRINT
K981091 · Zhermack S.P.A. · May 1998
SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL
K980965 · Cavex Holland BV · May 1998
KROMATICA COLOR CHANGING ALGINATE
K974894 · Matech, Inc. · Feb 1998
POSITION PENTA, POSITION PENTA QUICK
K974231 · Espe GmbH & Co. Kg. · Jan 1998