Cleared Traditional

K981514 - GC FUJI BOND LC

K981514 is an FDA 510(k) clearance for GC FUJI BOND LC, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K981514 · GC America, Inc. · Dental device
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Jun 1998
Decision
49d
Days
Class 2
Risk

K981514 is an FDA 510(k) clearance for the GC FUJI BOND LC. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on June 16, 1998 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 - K981514

510(k) Number K981514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1998
Decision Date June 16, 1998
Days to Decision 49 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
78d faster than avg
Panel avg: 127d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 372
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K981514.
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
K982394 · Dentsply Intl. · Sep 1998
TRUBYTE DENTURE BOND DENTURE BONDING AGENT
K982007 · Dentsply Intl. · Jul 1998
ALLOYBOND
K981383 · Southern Dental Industries, Inc. · Jun 1998
ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM
K974906 · Coltene/Whaledent, Inc. · Mar 1998
HURRISEAL DENTIN DESENSITIZER
K973002 · Cheng & Assoc., Inc. · Mar 1998
SOLOBOND M
K980539 · Voco GmbH · Mar 1998