Cleared Traditional

FIXAFLOSS

K071615 · Sybron Dental Specialties, Inc. · Dental
Sep 2007
Decision
100d
Days
Class 1
Risk

About This 510(k) Submission

K071615 is an FDA 510(k) clearance for the FIXAFLOSS, a Clamp, Rubber Dam (Class I — General Controls, product code EEF), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on September 21, 2007, 100 days after receiving the submission on June 13, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.6300.

Submission Details

510(k) Number K071615 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2007
Decision Date September 21, 2007
Days to Decision 100 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EEF — Clamp, Rubber Dam
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6300