Cleared Traditional

K091106 - EQUIA

K091106 is the FDA 510(k) clearance for EQUIA by GC America, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K091106 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
62d
Days
Class 2
Risk

K091106 is an FDA 510(k) clearance for the EQUIA. 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 June 17, 2009 after a review of 62 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

Submission Details

510(k) Number K091106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2009
Decision Date June 17, 2009
Days to Decision 62 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
65d faster than avg
Panel avg: 127d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 253
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K091106.
ADVANCED GLASS IONOMER (K-130) RESTORATIVE
K101493 · Dentsply International, Inc. · Aug 2010
RETRIEVE IMPLANT CEMENT
K101044 · Parkell, Inc. · Jun 2010
IONOLUX
K090817 · Voco GmbH · Jul 2009
SPEEDCEM
K091019 · Ivoclar Vivadent, Inc. · Jun 2009
BIFIX SE
K083438 · Voco GmbH · Feb 2009
BISCEM TRANSLUCENT, MODEL D-45011
K082449 · Bisco, Inc. · Sep 2008