Cleared Traditional

CAVI-ZYME

K922633 · E&D Dental Products, Inc. · Dental
Aug 1992
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K922633 is an FDA 510(k) clearance for the CAVI-ZYME, a Handle, Instrument, Dental (Class I — General Controls, product code EJB), submitted by E&D Dental Products, Inc. (Westfield, US). The FDA issued a Cleared decision on August 6, 1992, 78 days after receiving the submission on May 20, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K922633 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1992
Decision Date August 06, 1992
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJB — Handle, Instrument, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565