Cleared Traditional

CAVIDRY

K822896 · Parker Laboratories, Inc. · Dental
Oct 1982
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K822896 is an FDA 510(k) clearance for the CAVIDRY, a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 22, 1982, 23 days after receiving the submission on September 29, 1982. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K822896 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 1982
Decision Date October 22, 1982
Days to Decision 23 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code EJH — Alloy, Metal, Base
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3710