Cleared Traditional

ORTHODONTIC ACRYLIC (NOT FINALIZED)

K141439 · Bisco, Inc. · Dental
Sep 2014
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K141439 is an FDA 510(k) clearance for the ORTHODONTIC ACRYLIC (NOT FINALIZED), a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on September 12, 2014, 102 days after receiving the submission on June 2, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K141439 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2014
Decision Date September 12, 2014
Days to Decision 102 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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