Cleared Traditional

ORTHO-1(NOT FINALIZED)

K113401 · Bisco, Inc. · Dental
Feb 2012
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K113401 is an FDA 510(k) clearance for the ORTHO-1(NOT FINALIZED), a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on February 7, 2012, 82 days after receiving the submission on November 17, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K113401 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2011
Decision Date February 07, 2012
Days to Decision 82 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DYH — Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3750

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