Cleared Traditional

K991974 - FUTURA GLASS IONOMER SILVER REINFORCED

K991974 is an FDA 510(k) clearance for FUTURA GLASS IONOMER SILVER REINFORCED, manufactured by Ab Ardent. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K991974 · Ab Ardent · Dental device
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Sep 1999
Decision
98d
Days
Class 2
Risk

K991974 is an FDA 510(k) clearance for the FUTURA GLASS IONOMER SILVER REINFORCED. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Ab Ardent (Tonawanda, US). The FDA issued a Cleared decision on September 17, 1999 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ab Ardent devices

FDA 510(k) Submission Details - K991974

510(k) Number K991974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1999
Decision Date September 17, 1999
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
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 354
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K991974.
ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT
K994261 · Ultradent Products, Inc. · Feb 2000
MODIFICATION OF PARAPOST CEMENT
K993710 · Coltene/Whaledent, Inc. · Dec 1999
CARBOCEM ZINC POLYCARBOXYLATE CEMENT
K993324 · Scientific Pharmaceuticals, Inc. · Nov 1999
NEXUS 2
K992160 · Sybron Dental Specialties, Inc. · Aug 1999
BISTITE II SC
K991711 · Tokuyama America, Inc. · Jul 1999
TOTALBOND
K990381 · Parkell, Inc. · May 1999