Cleared Traditional

K001730 - GC FUJICEM

K001730 is an FDA 510(k) clearance for GC FUJICEM, 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 40-day FDA review.

K001730 · GC America, Inc. · Dental device
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Jul 2000
Decision
40d
Days
Class 2
Risk

K001730 is an FDA 510(k) clearance for the GC FUJICEM. 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 July 17, 2000 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 GC America, Inc. devices

FDA 510(k) Submission Details - K001730

510(k) Number K001730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2000
Decision Date July 17, 2000
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.

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 K001730.
HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT
K002461 · Shofu Dental Corp. · Sep 2000
KETAC CEM U
K002793 · Espe Dental AG · Sep 2000
LINKMAX
K001823 · GC America, Inc. · Aug 2000
CEMENT IT! UNIVERSAL C&B
K000173 · Jeneric/Pentron, Inc. · Feb 2000
ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT
K994261 · Ultradent Products, Inc. · Feb 2000
LIQUIBAND DENTAL
K993556 · Medlogic Global Corp. · Jan 2000