Cleared Traditional

K120521 - GC BLUE SILICONE

K120521 is an FDA 510(k) clearance for GC BLUE SILICONE, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K120521 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
79d
Days
Class 2
Risk

K120521 is an FDA 510(k) clearance for the GC BLUE SILICONE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on May 10, 2012 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 - K120521

510(k) Number K120521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2012
Decision Date May 10, 2012
Days to Decision 79 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 297
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K120521.
FLEXITIME FAST & SCAN LIGHT FLOW
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K113574 · Heraeus Kulzer, LLC · Jul 2012
TEMPSPAN CLEAR MATRIX
K120013 · Pentron Clinical · May 2012
FLASH (DIFFERENT MATERIALS)
K120438 · 3M Deutschland GmbH · May 2012
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL
K113406 · Dentsply International, Inc. · Feb 2012
ARGES IMAGING CONTRAST SPRAY
K113263 · Arges Imaging, Inc. · Nov 2011