Cleared Traditional

ETCH-RITE SUPREME

K120213 · Pulpdent Corporation · Dental
Mar 2012
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K120213 is an FDA 510(k) clearance for the ETCH-RITE SUPREME, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on March 30, 2012, 66 days after receiving the submission on January 24, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K120213 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2012
Decision Date March 30, 2012
Days to Decision 66 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