Cleared Traditional

REVOLUTION BOND

K953592 · E&D Dental Products, Inc. · Dental
Sep 1995
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K953592 is an FDA 510(k) clearance for the REVOLUTION BOND, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by E&D Dental Products, Inc. (Somerset, US). The FDA issued a Cleared decision on September 7, 1995, 37 days after receiving the submission on August 1, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K953592 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 1995
Decision Date September 07, 1995
Days to Decision 37 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