Cleared Traditional

ENAMEL PRO

K062166 · Premier Dental Products Co. · Dental
Nov 2006
Decision
116d
Days
Class 1
Risk

About This 510(k) Submission

K062166 is an FDA 510(k) clearance for the ENAMEL PRO, a Agent, Polishing, Abrasive, Oral Cavity (Class I — General Controls, product code EJR), submitted by Premier Dental Products Co. (Plymouth Meeting, US). The FDA issued a Cleared decision on November 21, 2006, 116 days after receiving the submission on July 28, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.6030.

Submission Details

510(k) Number K062166 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2006
Decision Date November 21, 2006
Days to Decision 116 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJR — Agent, Polishing, Abrasive, Oral Cavity
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6030