Cleared Traditional

PULPDENT ETCH-RITE ROYALE

K031915 · Pulpdent Corporation · Dental
Aug 2003
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K031915 is an FDA 510(k) clearance for the PULPDENT ETCH-RITE ROYALE, 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 August 5, 2003, 46 days after receiving the submission on June 20, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K031915 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2003
Decision Date August 05, 2003
Days to Decision 46 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