Cleared Traditional

TRAXODENT

K083695 · Premier Dental Products Co. · Dental
Apr 2009
Decision
134d
Days
—
Risk

About This 510(k) Submission

K083695 is an FDA 510(k) clearance for the TRAXODENT, a Cord, Retraction, submitted by Premier Dental Products Co. (Plymouth Meeting, US). The FDA issued a Cleared decision on April 28, 2009, 134 days after receiving the submission on December 15, 2008. This device falls under the Dental review panel.

Submission Details

510(k) Number K083695 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2008
Decision Date April 28, 2009
Days to Decision 134 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code MVL — Cord, Retraction
Device Class —