Cleared Traditional

VERSA-LINK PORCELAIN BONDING SYSTEM

K052699 · Sultan Chemists, Inc. · Dental
Nov 2005
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K052699 is an FDA 510(k) clearance for the VERSA-LINK PORCELAIN BONDING SYSTEM, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Sultan Chemists, Inc. (Englewood, US). The FDA issued a Cleared decision on November 16, 2005, 49 days after receiving the submission on September 28, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K052699 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2005
Decision Date November 16, 2005
Days to Decision 49 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200