Cleared Traditional

K950556 - FUJI ORTHO LC

K950556 is the FDA 510(k) clearance for FUJI ORTHO LC by GC America, Inc.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K950556 · GC America, Inc. · Dental device
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Mar 1995
Decision
29d
Days
Class 2
Risk

K950556 is an FDA 510(k) clearance for the FUJI ORTHO LC. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on March 8, 1995 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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

Submission Details

510(k) Number K950556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1995
Decision Date March 08, 1995
Days to Decision 29 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
98d faster than avg
Panel avg: 127d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 81
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K950556.
GC FUJI ORTHO
K961417 · GC America, Inc. · May 1996
PULPDENT TOUCHDOWN
K953217 · Pulpdent Corp. · Aug 1995
PULPDENT GLASS IONOMER CEMENTS
K952854 · Pulpdent Corp. · Jul 1995
THERMASET
K946255 · Ormco Corp. · Jan 1995
SYSTEM 1
K940845 · Sybron Dental Specialties, Inc. · Mar 1994
ORMCO SYSTEM 1+ (TM)
K941015 · Ormco Corp. · Mar 1994