Cleared Traditional

PRIMER PLUS

K091705 · Bisco, Inc. · Dental
Aug 2009
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K091705 is an FDA 510(k) clearance for the PRIMER PLUS, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on August 28, 2009, 79 days after receiving the submission on June 10, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K091705 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2009
Decision Date August 28, 2009
Days to Decision 79 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200