Cleared Traditional

K993973 - FUJI II LC CAPSULE

K993973 is an FDA 510(k) clearance for FUJI II LC CAPSULE, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K993973 · GC America, Inc. · Dental device
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Jan 2000
Decision
49d
Days
Class 2
Risk

K993973 is an FDA 510(k) clearance for the FUJI II LC CAPSULE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on January 11, 2000 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 - K993973

510(k) Number K993973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1999
Decision Date January 11, 2000
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.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 782
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K993973.
RENAMEL SCULPT
K993658 · Cosmedent, Inc. · Jan 2000
RENAMEL PACK
K993659 · Cosmedent, Inc. · Jan 2000
ADMIRA
K994056 · Voco GmbH · Jan 2000
KETAC-MOLAR QUICK
K994251 · Espe Dental AG · Jan 2000
SOLITAIRE 2
K993932 · Heraeus Kulzer, Inc. · Dec 1999
PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE
K993716 · Harry J. Bosworth Co. · Dec 1999