Cleared Traditional

GC Reline II

K153253 · GC America, Inc. · Dental
Mar 2016
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K153253 is an FDA 510(k) clearance for the GC Reline II, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on March 3, 2016, 114 days after receiving the submission on November 10, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K153253 FDA.gov
FDA Decision Cleared SESE
Date Received November 10, 2015
Decision Date March 03, 2016
Days to Decision 114 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

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