Cleared Traditional

K982779 - MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1

K982779 is an FDA 510(k) clearance for MEDENTAL GLASS IONOMER CEMENT TYPE I AN..., manufactured by Medental Intl.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K982779 · Medental Intl. · Dental device
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Sep 1998
Decision
54d
Days
Class 2
Risk

K982779 is an FDA 510(k) clearance for the MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Medental Intl. (Lakewood, US). The FDA issued a Cleared decision on September 30, 1998 after a review of 54 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 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 Medental Intl. devices

FDA 510(k) Submission Details - K982779

510(k) Number K982779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1998
Decision Date September 30, 1998
Days to Decision 54 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 127d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 387
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K982779.
ZINFOS ZINC PHOSPHATE CEMENT
K982913 · Scientific Pharmaceuticals, Inc. · Oct 1998
STERNOMEGA COMPOMER CEMENT
K982895 · Sterngold/Implamed · Oct 1998
TEMPBOND CLEAR-2
K982590 · Sybron Dental Specialties, Inc. · Oct 1998
STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT
K982400 · Steri-Oss, Inc. · Sep 1998
JUMBO SILVER-REINFORCED GLASS IONOMER
K982665 · Centrix, Inc. · Sep 1998
GLASIONOMER CEMENT CX PLUS
K982461 · Shofu Dental Corp. · Aug 1998