Cleared Traditional

KNIT-PAK+

K132526 · Premier Dental Products Co. · Dental
Nov 2013
Decision
106d
Days
—
Risk

About This 510(k) Submission

K132526 is an FDA 510(k) clearance for the KNIT-PAK+, a Cord, Retraction, submitted by Premier Dental Products Co. (Plymouth Meeting, US). The FDA issued a Cleared decision on November 26, 2013, 106 days after receiving the submission on August 12, 2013. This device falls under the Dental review panel.

Submission Details

510(k) Number K132526 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2013
Decision Date November 26, 2013
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code MVL — Cord, Retraction
Device Class —