Cleared Traditional

K980682 - FUJI II

K980682 is an FDA 510(k) clearance for FUJI II, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K980682 · GC America, Inc. · Dental device
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Apr 1998
Decision
39d
Days
Class 2
Risk

K980682 is an FDA 510(k) clearance for the FUJI II. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on April 3, 1998 after a review of 39 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 GC America, Inc. devices

FDA 510(k) Submission Details - K980682

510(k) Number K980682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1998
Decision Date April 03, 1998
Days to Decision 39 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
88d faster than avg
Panel avg: 127d · This submission: 39d
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 421
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K980682.
FUJI I
K980695 · GC America, Inc. · Apr 1998
PERIACRYL
K974097 · Blacklock Medical Products, Inc. · Apr 1998
OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01
K980159 · Closure Medical Corp. · Apr 1998
CLEARFIL DC CEMENT
K980232 · Kuraray Company, Ltd. · Feb 1998
COMPOLUTE APLICAP
K974458 · Espe Dental-Medizin GmbH & Co.Kg. · Feb 1998
SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL
K972935 · S.S. White Mfg., Ltd. · Jan 1998