Cleared Traditional

EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT

K032953 · Pulpdent Corporation · Dental
Dec 2003
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K032953 is an FDA 510(k) clearance for the EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT, 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 December 10, 2003, 79 days after receiving the submission on September 22, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K032953 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2003
Decision Date December 10, 2003
Days to Decision 79 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