Cleared Traditional

K982461 - GLASIONOMER CEMENT CX PLUS

K982461 is the FDA 510(k) clearance for GLASIONOMER CEMENT CX PLUS by Shofu Dental Corp.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K982461 · Shofu Dental Corp. · Dental device
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Aug 1998
Decision
40d
Days
Class 2
Risk

K982461 is an FDA 510(k) clearance for the GLASIONOMER CEMENT CX PLUS. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Shofu Dental Corp. (Menlo Park, US). The FDA issued a Cleared decision on August 24, 1998 after a review of 40 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 Shofu Dental Corp. devices

Submission Details

510(k) Number K982461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1998
Decision Date August 24, 1998
Days to Decision 40 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
87d faster than avg
Panel avg: 127d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 219
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K982461.
MIRACLE MIX POWDER/LIQUID
K984505 · GC America, Inc. · Feb 1999
ZINFOS ZINC PHOSPHATE CEMENT
K982913 · Scientific Pharmaceuticals, Inc. · Oct 1998
TEMPBOND CLEAR-2
K982590 · Sybron Dental Specialties, Inc. · Oct 1998
FLOWABLE COMPOSITE
K981965 · Dentsply Intl. · Jul 1998
ARISTON PHC LINER
K981335 · Ivoclar North America, Inc. · Jul 1998
MIRACLE MIX CAPSULE
K981370 · GC America, Inc. · Jun 1998